The following data is part of a premarket notification filed by Eyetronics, Inc. with the FDA for Model 100 Visual Evoked Response Recording System.
| Device ID | K872725 |
| 510k Number | K872725 |
| Device Name: | MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | EYETRONICS, INC. 4849 GRIZZLY PEAK BLVD. Berkeley, CA 94705 |
| Contact | Marg, O.d.,phd |
| Correspondent | Marg, O.d.,phd EYETRONICS, INC. 4849 GRIZZLY PEAK BLVD. Berkeley, CA 94705 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-08-14 |