The following data is part of a premarket notification filed by Sophono, Inc with the FDA for Otomag Bone Conducation Hearing System.
| Device ID | K132189 |
| 510k Number | K132189 |
| Device Name: | OTOMAG BONE CONDUCATION HEARING SYSTEM |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | SOPHONO, INC 5744 CENTRAL AVENUE #100 Boulder, CO 80301 |
| Contact | Krista B Traynor |
| Correspondent | Krista B Traynor SOPHONO, INC 5744 CENTRAL AVENUE #100 Boulder, CO 80301 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169645349 | K132189 | 000 |
| 00643169645332 | K132189 | 000 |
| 00643169645325 | K132189 | 000 |
| 00643169644649 | K132189 | 000 |
| 00643169644632 | K132189 | 000 |
| 00643169644625 | K132189 | 000 |