21 CFR 870.2300
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.2300, § 870.2300 Cardiac monitor (including cardiotachometer and rate alarm), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89918
- Permanent ID
ys:prov:89918@1- SHA-256
24b3952bbe871c9690daf23cbc650cc33d6f88769fcf4e6125cca2ea04adf2ef
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.