CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART C—Cardiovascular Monitoring Devices (§870.2050 to §870.2920) > 870.2300—Cardiac monitor (including cardiotachometer and rate alarm).

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).