21 C.F.R. § 868.5620 Breathing mouthpiece.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5620 Breathing mouthpiece.
