Code of Federal Regulations · Section
§ 868.5330 — Breathing Gas Mixer
21 C.F.R. § 868.5330
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(a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351