Code of Federal Regulations (Last Updated: May 6, 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 |
§ 868.5470 - Hyperbaric chamber.
Latest version.
-
§ 868.5470 Hyperbaric chamber.
(a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).
(b) Classification. Class II (performance standards).