21 CFR § 868.5470 Anesthesiology Devices

§ 868.5470 Hyperbaric chamber.

Current through Sep 8, 2026 · Read all of Part 868

(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).

← § 868.5460 Therapeutic humidifier for home use.§ 868.5480 Isocapnic ventilation device. →