21 CFR § 886.1690 - Pupillograph.

(a) Identification. A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.

(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 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]