21 C.F.R. § 878.4160

Current through April 30, 2024
Section 878.4160 - Surgical camera and accessories
(a)Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.
(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 § 878.9 .

21 C.F.R. §878.4160

53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, 2001