(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]