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§868.5470. Hyperbaric chamber.

21 C.F.R. § 868.5470

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.