21 C.F.R. § 878.4160 Surgical camera and accessories.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4160 Surgical camera and accessories.
