21 C.F.R. § 868.5440

Portable oxygen generator.

Last amended: 2016Year: 2026Length: 38 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 868.5440 (2026)

(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).
21 C.F.R. § 868.5440: Portable oxygen generator. | Justis AI