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Title 21 Part 868 → Subpart F → §868.5470

Title 21 → Chapter I → Subchapter H → Part 868 → Subpart F → §868.5470

Electronic Code of Federal Regulations e-CFR

Title 21 Part 868 → Subpart F → §868.5470

e-CFR data is current as of January 24, 2020

Title 21Chapter ISubchapter HPart 868Subpart F → §868.5470


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices


§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).