The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Speechlink 100 Type 1053.
| Device ID | K061104 |
| 510k Number | K061104 |
| Device Name: | SPEECHLINK 100 TYPE 1053 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | GN OTOMETRICS A/S DYBENDALSVAENGET 2 P.O. BOX 119 Taastrup, DK Dk-2630 |
| Contact | Per Pape Thomsen |
| Correspondent | Daniel W Lehtonen 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 | 2006-04-20 |
| Decision Date | 2006-05-03 |
| Summary: | summary |