COMPUTERIZED ELECTRO-OCULOGRAPH
Device Facts
| Record ID | K790637 |
|---|---|
| Device Name | COMPUTERIZED ELECTRO-OCULOGRAPH |
| Applicant | Potomac Medical System |
| Product Code | HLX · Ophthalmic |
| Decision Date | Aug 28, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).
