§ 868.2550. Pneumotachometer.
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/us/cfr/t21/s§ 868.2550·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]