HRI · Pupillograph
Ophthalmic · 21 CFR 886.1690 · Class 1
Overview
| Product Code | HRI |
|---|---|
| Device Name | Pupillograph |
| Regulation | 21 CFR 886.1690 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
