21 CFR 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).