The following data is part of a premarket notification filed by Synapsys Sa with the FDA for Synapsys Ulmer Video Nystagmograph.
| Device ID | K163558 |
| 510k Number | K163558 |
| Device Name: | Synapsys Ulmer Video Nystagmograph |
| Classification | Nystagmograph |
| Applicant | Synapsys SA Marseille, FR 13013 |
| Contact | Laetitia Baconnier |
| Correspondent | Rachel Paul Emergo Europe Consulting Prinsessegracht 20 The Hague, NL 2514ap |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-03-23 |
| Summary: | summary |