21 CFR § 870.2300 Cardiovascular Devices

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

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.2220 Adjunctive hemodynamic indicator with decision point.§ 870.2310 Apex cardiograph (vibrocardiograph). →