21 CFR 868.1840 - Diagnostic spirometer.

Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart B [§ 868.1030 - § 868.1975]

§ 868.1840 - Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

(b) Classification. Class II (performance standards).

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 47 FR 31142, July 16, 1982, unless otherwise noted.

cite as: 21 CFR 868.1840