The following data is part of a premarket notification filed by Sophono, Inc with the FDA for Otomag Bone Conduction Hearing System Model Alpha 1 (s) And Alpha 1 (m).
| Device ID | K102199 |
| 510k Number | K102199 |
| Device Name: | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | SOPHONO, INC 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo SOPHONO, INC 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-04 |
| Decision Date | 2011-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169649071 | K102199 | 000 |
| 00643169644762 | K102199 | 000 |
| 00643169644755 | K102199 | 000 |
| 00643169644748 | K102199 | 000 |
| 00643169644731 | K102199 | 000 |
| 00643169644717 | K102199 | 000 |
| 00643169644700 | K102199 | 000 |
| 00643169644694 | K102199 | 000 |
| 00643169644687 | K102199 | 000 |
| 00643169644670 | K102199 | 000 |
| 00643169644663 | K102199 | 000 |
| 00643169644656 | K102199 | 000 |
| 09120041051661 | K102199 | 000 |
| 00643169644779 | K102199 | 000 |
| 00643169644786 | K102199 | 000 |
| 00643169645301 | K102199 | 000 |
| 00643169644892 | K102199 | 000 |
| 00643169644885 | K102199 | 000 |
| 00643169644878 | K102199 | 000 |
| 00643169644861 | K102199 | 000 |
| 00643169644854 | K102199 | 000 |
| 00643169644847 | K102199 | 000 |
| 00643169644830 | K102199 | 000 |
| 00643169644823 | K102199 | 000 |
| 00643169644816 | K102199 | 000 |
| 00643169644809 | K102199 | 000 |
| 00643169644793 | K102199 | 000 |
| 09120041051500 | K102199 | 000 |