F110 PHOTO BINOCULAR OPHTHALMOSCOPE
Device Facts
| Record ID | K802351 |
|---|---|
| Device Name | F110 PHOTO BINOCULAR OPHTHALMOSCOPE |
| Applicant | Minami, Tomine & Lew |
| Product Code | HLG · Ophthalmic |
| Decision Date | Dec 17, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.
