Code of Federal Regulations · Section
§ 868.5440 — Portable Oxygen Generator
21 C.F.R. § 868.5440
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(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351