The following data is part of a premarket notification filed by Potomac Medical System with the FDA for Computerized Electro-oculograph.
| Device ID | K790637 |
| 510k Number | K790637 |
| Device Name: | COMPUTERIZED ELECTRO-OCULOGRAPH |
| Classification | Photostimulator, Ac-powered |
| Applicant | POTOMAC MEDICAL SYSTEM 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-02 |
| Decision Date | 1979-08-28 |