MODIFICATION TO EDI VERIS SYSTEM
Device Facts
| Record ID | K003442 |
|---|---|
| Device Name | MODIFICATION TO EDI VERIS SYSTEM |
| Applicant | Electro-Diagnostic Imaging, Inc. |
| Product Code | HLX · Ophthalmic |
| Decision Date | May 4, 2001 |
| 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).
