21 C.F.R. § 868.5470

Current through September 30, 2024
Section 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).

21 C.F.R. § 868.5470