Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart B - Diagnostic Devices / § 868.1850 Monitoring spirometer.
§ 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).