Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 868 - Anesthesiology Devices |
Subpart F - Therapeutic Devices |
§ 868.5440 - Portable oxygen generator.
Latest version.
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§ 868.5440 Portable oxygen generator.
(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).