21 CFR 868.2375

§ 868.2375 Breathing frequency monitor.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 868.2375, § 868.2375 Breathing frequency monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89752
Permanent ID: ys:prov:89752@1
SHA-256: b572b30697e6ffaa265cb24db29cc57851484b2b411987fede3c853a1f7a4075

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Full text

(a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377. (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.