21 C.F.R. § 868.5530

Current through November 30, 2024
Section 868.5530 - Flexible laryngoscope
(a)Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
(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 .

21 C.F.R. §868.5530

47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795 , July 25, 2001