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§ 868.1850 Monitoring spirometer.

21 CFR 868.1850

Citation21 CFR 868.1850
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 868.1850 Monitoring spirometer.

(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).