Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 868.5570 Nonrebreathing mask.
§ 868.5570 Nonrebreathing mask.
(a) Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.