21 CFR 868.5440 — Generator, Oxygen, Portable

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5440

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).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CAWGenerator, Oxygen, Portable22853rd Party
OLFMedevac Use Oxygen Generator21Life-Sustaining
Innolitics

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