21 CFR § 868.1850 Anesthesiology Devices

§ 868.1850 Monitoring spirometer.

Current through Sep 8, 2026 · Read all of Part 868

(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).

← § 868.1840 Diagnostic spirometer.§ 868.1860 Peak-flow meter for spirometry. →