21 C.F.R. § 868.1850

Current through October 31, 2024
Section 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).

21 C.F.R. § 868.1850