The following data is part of a premarket notification filed by Synapsys, Inc. with the FDA for Ulmer (vng) Video Nystagmograph.
| Device ID | K982103 |
| 510k Number | K982103 |
| Device Name: | ULMER (VNG) VIDEO NYSTAGMOGRAPH |
| Classification | Nystagmograph |
| Applicant | SYNAPSYS, INC. 1400 MAIN ST. Louisville, CO 80027 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe SYNAPSYS, INC. 1400 MAIN ST. Louisville, CO 80027 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1998-09-11 |