21 C.F.R. § 868.5620

Current through October 31, 2024
Section 868.5620 - Breathing mouthpiece
(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 .

21 C.F.R. §868.5620

47 FR 31142, July 16, 1982, as amended at 65 FR 2313 , Jan. 14, 2000