The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Vn415m, Vn415b, Vo425m, V0425b, 2d-vog Goggles, 2d-vog System.
| Device ID | K072254 |
| 510k Number | K072254 |
| Device Name: | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM |
| Classification | Nystagmograph |
| Applicant | INTERACOUSTICS A/S 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Contact | Daniel Eggan |
| Correspondent | Daniel Eggan INTERACOUSTICS A/S 7625 GOLDEN TRIANGLE DRIVE Eden Prairie, MN 55344 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-14 |
| Decision Date | 2008-02-05 |
| Summary: | summary |