The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Gn Otometrics Type 1053 Freefit.
| Device ID | K110286 |
| 510k Number | K110286 |
| Device Name: | GN OTOMETRICS TYPE 1053 FREEFIT |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | GN OTOMETRICS A/S 125 COMMERCE DRIVE Schaumburg, IL 60173 -5329 |
| Contact | Tom Riniker |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315008184 | K110286 | 000 |
| 05713315005848 | K110286 | 000 |
| 05713315001055 | K110286 | 000 |
| 05713315001161 | K110286 | 000 |
| 05713315001192 | K110286 | 000 |
| 05713315001208 | K110286 | 000 |
| 05713315001215 | K110286 | 000 |
| 05713315001222 | K110286 | 000 |
| 05713315001246 | K110286 | 000 |
| 05713315001253 | K110286 | 000 |
| 05713315001277 | K110286 | 000 |
| 05713315003301 | K110286 | 000 |
| 05713315004100 | K110286 | 000 |
| 05713315004117 | K110286 | 000 |
| 05713315005701 | K110286 | 000 |
| 05713315008689 | K110286 | 000 |