21 C.F.R. § 886.1810 Tangent screen (campimeter).
Title 21 - Food and Drugs
(a) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters. (b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. The battery-powered device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1810 Tangent screen (campimeter).
