21 CFR 868.1850
§ 868.1850 Monitoring spirometer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.1850, § 868.1850 Monitoring spirometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89732
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Full text
(a) Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
(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.