OT:RR:CTF:EMAIN H338599 MFT
Center Director, Pharmaceuticals, Health and Chemicals C.E.E.
Service Port of Chicago
Chicago O’Hare International Airport, Terminal 55
10000 Bessie Coleman Drive
Chicago, IL 60666
Re: Application for Further Review of Protest No. 3901-23-128434; Classification of Pulse Oximeters
Dear Center Director:
The following is our decision on the Application for Further Review (AFR) of Protest No. 3901-23-128434, which was filed on February 7, 2023, on behalf of Veridian Healthcare, LLC (Protestant). The protest pertains to the classification under the Harmonized Tariff Schedule of the United States (HTSUS) by U.S. Customs and Border Protection (CBP) of certain pulse oximeters.
FACTS:
The merchandise at issue consists of certain pulse oximeters from China. The subject pulse oximeters are used to measure the concentration of oxygen in blood, specifically oxygen saturation of arterial hemoglobin (SpO2). The protestant indicates that calculations from the subject pulse oximeters “can be used by the healthcare provider to decide if a person needs to seek medical attention and may need extra oxygen.” The pulse oximeters clip onto a user’s fingertip and take non-invasive measurements. Infrared light emits from one side of the clip, transmits through the user’s capillaries in the finger, and is received by a receptor on the other side of the clip. Color changes that occur over time represent oxygenation levels, which is calculated and displayed as functional oxygen saturation. The device also displays a user’s pulse rate in beats per minute (bpm).
The subject pulse oximeters operate with an SpO2 accuracy of a root-mean square difference of less than or equal to 4.0% over the range of 70% to 100% of oxygenated hemoglobin (SaO2). The protestant indicates that these results were confirmed by a controlled desaturation study, which examined blood oxygen saturation levels compared to arterial CO-oximetry. Further, the protestant demonstrates that the subject pulse oximeters are accurate under conditions of low perfusion at 0.4%, and that the merchandise displays pulse rate data over a range of 30 to 250 bpm +/- 2 bpm. The subject pulse oximeters are not equipped with an alarm; they are not intended for use in laboratory research applications, ambulances, or air transport; and they do not require a blood sample from a patient. The pulse oximeters also provide a warning to the user when the signal is inadequate.
The subject merchandise was entered from November 12, 2021, through August 14, 2022, under heading 9018, HTSUS, which provides for, “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof.” CBP liquidated the merchandise from October 28, 2022, through December 16, 2022, under heading 9029, HTSUS, which provides for “Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9015; stroboscopes; parts and accessories thereof.”
ISSUE:
Whether the subject pulse oximeters are classified under heading 9018, HTSUS, as “instruments used in medical sciences,” or under heading 9029, HTSUS, as “tachometers.”
LAW AND ANALYSIS:
This matter is protestable under 19 U.S.C. § 1514(a)(2) as it regards a CBP decision on classification. This protest was timely filed, within 180 days of liquidation of the first entry. Further review of this protest is properly accorded to the protestant pursuant to 19 C.F.R. § 174.24(a) because the protestant alleges that CBP’s liquidation of the subject merchandise under heading 9029, HTSUS, is inconsistent with prior CBP decisions with respect to the same or substantially similar merchandise. Specifically, the protestant claims CBP failed to follow New York Ruling Letter (NY) N144735 (Feb. 11, 2011) where we classified a certain pulse oximeter from China under heading 9018, HTSUS.
Classification under the HTSUS is in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order.
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are generally indicative of the proper interpretation of the heading.
The HTSUS headings under consideration are as follows:
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:
* * * * *
9029 Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9015; stroboscopes; parts and accessories thereof:
The resolution of this case rests on GRI 1. To be classified under this rule, the subject merchandise must meet the terms of either heading 9018, HTSUS, as “instruments used in medical sciences,” or heading 9029, HTSUS, as “tachometers.” If one heading describes the subject merchandise in whole, we must apply that heading and end our analysis. In conducting this analysis, we observe the well-established principle that “in order to produce uniformity in the imposition of duties, the dutiable classification of articles imported must be ascertained by an examination of the imported article itself, in the condition in which it is imported.”
We note that neither the HTSUS nor the ENs define the term “tachometer.” Courts have found that in the absence of a definition of a term in the HTSUS or ENs, the term’s correct meaning is its “common and commercial meaning.” The common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities, and other reliable sources. A previous CBP ruling examined the term “tachometer” and found that it included certain articles that measure a person’s pulse rate. In Headquarters Ruling Letter (HQ) 087550 (Feb. 28, 1991), we concluded that “[t]here is ample support for the position that articles which measure pulse and heart rate are specialized types of tachometers described as hemotachometers and cardiotachometers.” In particular:
The Random House Dictionary of the English Language, Random House, Inc. (1973), defines "tachometer" as follows:
1. any of various instruments for measuring or indicating velocity or speed, as of a machine, a river, the blood, etc. . . .
The International Dictionary of Medicine and Biology, John Wiley & Sons (1986), defines "tachometer" as follows:
An instrument that measures speed or rate, such as a cardiotachometer . . .
Stedman's Medical Dictionary, 23rd Ed., Williams & Wilkins Company (1976) defines "tachometer" as follows:
An instrument for measuring the speed or rate of something; e.g., revolutions of a shaft, heart rate (cardiotachometer), arterial blood flow (hemotachometer) . . .
See also Taber's Cyclopedic Medical Dictionary, 14th Ed., F. A. Davis Company (1981); Gould's Medical Dictionary, 5th Ed., The Blakiston Company (1941).
Taking these definitions into account, we found that the common and commercial meaning of the term “tachometer” under heading 9029, HTSUS, included certain instruments that measure or indicate speed, velocity, or rate – including medical instruments that measure or indicate a patient’s heart rate. Accordingly, we held in NY N144735 that a certain pulse oximeter from China “designed to measure an individual’s pulse oxygen saturation and pulse rate through one’s finger” was classified under heading 9018, HTSUS. The pulse oximeter at issue in that ruling could deliver SpO2 readings that can “assist a doctor in promptly diagnosing a patient and planning a course of treatment accordingly” as well as pulse rate data. Technical information from the device manual indicated that the pulse oximeter there was accurate to within 2% SpO2 between the measuring range of 70% to 100%, and that it was accurate to within 2 bpm between 30 and 250 bpm.
The EN to heading 9018, HTSUS, provides as follows, in relevant part:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc.
The EN to heading 9029, HTSUS, provides as follows, in relevant part:
This heading includes: [. . .]
Apparatus indicating a speed of revolution or a linear speed in relation to a time factor (tachometers and speed indicators), other than those of heading 90.14 or 90.15. [. . .]
(B) SPEED INDICATORS AND TACHOMETERS
These instruments differ from the revolution counters and production counters of Part (A) above in that they indicate the number of revolutions, speed, output, etc., per unit of time (e.g., revolutions per minute, miles per hour, kilometres per hour, metres per minute). They are usually mounted on vehicles (cars, motorcycles, bicycles, locomotives, etc.) or machines (motors, turbines, paper making machines, printing machinery, textile machinery, etc.). [. . .]
Speed indicators and tachometers of this heading may be fixed or portable, simple or multi function (e.g., maximum or minimum), differential (in which case they give the difference between two speeds as a percentage), combined with an adding counter or a time meter or graphical recording device, etc. The heading also covers certain instruments which simultaneously record speed, mileage, time in motion and at a standstill, etc.
We find that while heading 9029, HTSUS, refers to part of the subject merchandise, the pulse oximeters in their condition at importation are wholly described by heading 9018, HTSUS, and are thus classifiable therein.
As we found in HQ 087550, the common and commercial meaning of the term “tachometer” includes certain medical instruments that measure a person’s heart rate. This measurement of heart rate over a unit of time (i.e., beats per minute) tracks the guidance provided by the EN to heading 9029, HTSUS, that instruments classifiable under this heading “indicate the number of revolutions, speed, output, etc., per unit of time (e.g., revolutions per minute, miles per hour, kilometers per hour, metres per minute).” As such, heading 9029, HTSUS, describes the heart rate measurement function of the subject pulse oximeters. But even so, the terms of heading 9029, HTSUS, specifically “instruments used in medical sciences,” fully describe the subject merchandise in its condition at importation, not just a particular function of the oximeters.
Since the subject pulse oximeters, in their condition at importation, possess the general characteristics of devices used to aid medical professionals in diagnosing certain conditions through pulse oximetry, they fully meet the terms of heading 9018, HTSUS, as “instruments used in the medical sciences.” As shown above, the subject pulse oximeters operate with an SpO2 accuracy of a root-mean square difference of less than or equal to 4.0% over the range of 70% to 100% of SaO2. A controlled desaturation study, comparing blood oxygen saturation levels to arterial CO-oximetry verified these results. Moreover, the subject merchandise provides a warning to the user when the signal is inadequate. The record demonstrates that these pulse oximeters can be used by a medical professional to aid in the diagnosis of certain conditions associated with low blood-oxygen levels, and these results “can be used by the healthcare provider to decide if a person needs to seek medical attention and may need extra oxygen.” Given this functionality, we find that the subject merchandise meets the terms of heading 9018, HTSUS, as “instruments used in the medical sciences” in their condition at importation.
HOLDING:
By application of GRIs 1 and 6, the subject pulse oximeters are classified under heading 9018, HTSUS, specifically subheading 9018.19.95, HTSUS, which provides for, “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Other.” The general column one rate of duty is free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.95, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty.
The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.
You are instructed to GRANT the Protest.
You are instructed to notify the Protestant of this decision no later than 60 days from the date of this decision. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to this notification. Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings will make the decision available to CBP personnel and the public on the Customs Rulings Online Search System (CROSS) at https://rulings.cbp.gov/, or other methods of public distribution.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division