§ 878.4160. Surgical camera and accessories.
70 words·~1 min read·
/us/cfr/t21/s§ 878.4160·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, 2001]