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Code · CFR · Title 21 — Food and Drugs · Part 870 — Cardiovascular Devices · § 870.2300

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

55 words·~1 min read·/us/cfr/t21/s§ 870.2300·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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).
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