The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Focus Vng/eng Type 1068.
| Device ID | K061791 |
| 510k Number | K061791 |
| Device Name: | FOCUS VNG/ENG TYPE 1068 |
| Classification | Nystagmograph |
| Applicant | GN OTOMETRICS A/S 125 COMMERCE DRIVE Schaumburg, IL 60173 -5329 |
| Contact | Michael Hamacher |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315004971 | K061791 | 000 |
| 05713315002694 | K061791 | 000 |
| 05713315002687 | K061791 | 000 |
| 05713315002656 | K061791 | 000 |
| 05713315002649 | K061791 | 000 |