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e-CFR data is current as of August 12, 2020

Title 21Chapter ISubchapter HPart 868Subpart B → §868.1850


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices


§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).

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