Regulatory Text
21 C.F.R. § 868.2550 — Pneumotachometer.
§ 868.2550 Pneumotachometer. (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]
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Citation
21 C.F.R. § 868.2550
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CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 868.2550 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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