The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Eyeseecam Vhit.
| Device ID | K131681 |
| 510k Number | K131681 |
| Device Name: | EYESEECAM VHIT |
| Classification | Nystagmograph |
| Applicant | INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610 |
| Contact | Erik Nielsen |
| Correspondent | Erik Nielsen INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-09-06 |
| Summary: | summary |