21 CFR 886.1690 — Pupillograph

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1690

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HRIPupillograph10
Innolitics

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