21 CFR § 878.4160 - Surgical camera and accessories.
§ 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.