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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

21 CFR 870.2300

Citation21 CFR 870.2300
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 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).