Monitoring spirometer.

21 C.F.R. § 868.1850
in effectEffective: 2024-07-01
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(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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