21 CFR 868.5470 — Chamber, Hyperbaric

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5470

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).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CBFChamber, Hyperbaric2693rd Party, Life-Sustaining
Innolitics

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