Hyperbaric chamber.

21 C.F.R. § 868.5470
in effectEffective: 2024-07-01
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(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).

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