5011 GANZFELD STIMULATOR
Device Facts
| Record ID | K822922 |
|---|---|
| Device Name | 5011 GANZFELD STIMULATOR |
| Applicant | Life-Tech Intl., Inc. |
| Product Code | HLX · Ophthalmic |
| Decision Date | Dec 28, 1982 |
| 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).
