21 C.F.R. § 870.2300

Cardiac monitor (including cardiotachometer and rate alarm).

Last amended: 2016Year: 2026Length: 55 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 870.2300 (2026)

(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).
21 C.F.R. § 870.2300: Cardiac monitor (including cardiotachometer and rate alarm). | Justis AI