§ 878.4700. Surgical microscope and accessories.
77 words·~1 min read·
/us/cfr/t21/s§ 878.4700·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
(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. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]