Regulations last checked for updates: May 03, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm).

(a) Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

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

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
cite as: 21 CFR 870.2300