21 C.F.R. § 886.1070 Anomaloscope.
Title 21 - Food and Drugs
(a) Identification. An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient. (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 §886.9. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1070 Anomaloscope.
