§ 868.5580. Oxygen mask.
73 words·~1 min read·
/us/cfr/t21/s§ 868.5580·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
(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]