§ 868.5620. Breathing mouthpiece.
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/us/cfr/t21/s§ 868.5620·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
(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 § 868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]