§ 868.5570. Nonrebreathing mask.
81 words·~1 min read·
/us/cfr/t21/s§ 868.5570·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]