The following data is part of a premarket notification filed by Sophono, Inc with the FDA for Otomag Bone Conduction Hearing System.
| Device ID | K100193 |
| 510k Number | K100193 |
| Device Name: | OTOMAG BONE CONDUCTION HEARING SYSTEM |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | SOPHONO, INC 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Mary Armstrong |
| Correspondent | Mary Armstrong 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 | 2010-01-22 |
| Decision Date | 2010-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169841796 | K100193 | 000 |
| 00643169645271 | K100193 | 000 |
| 00643169645264 | K100193 | 000 |
| 00643169645042 | K100193 | 000 |
| 00643169645035 | K100193 | 000 |
| 00643169645028 | K100193 | 000 |
| 00643169645011 | K100193 | 000 |
| 00643169645004 | K100193 | 000 |
| 00643169644991 | K100193 | 000 |
| 00643169644984 | K100193 | 000 |
| 00643169644977 | K100193 | 000 |
| 00643169644960 | K100193 | 000 |
| 00643169644595 | K100193 | 000 |
| 00643169644588 | K100193 | 000 |
| 00643169644571 | K100193 | 000 |
| 00643169645288 | K100193 | 000 |
| 00643169645295 | K100193 | 000 |
| 00643169648975 | K100193 | 000 |
| 00643169799844 | K100193 | 000 |
| 00643169799837 | K100193 | 000 |
| 00643169799820 | K100193 | 000 |
| 00643169671553 | K100193 | 000 |
| 00643169671546 | K100193 | 000 |
| 00643169671539 | K100193 | 000 |
| 00643169671522 | K100193 | 000 |
| 00643169671515 | K100193 | 000 |
| 00643169671508 | K100193 | 000 |
| 00643169671492 | K100193 | 000 |
| 00643169671485 | K100193 | 000 |
| 00643169671478 | K100193 | 000 |
| 00643169649064 | K100193 | 000 |
| 00643169649026 | K100193 | 000 |
| 00643169644564 | K100193 | 000 |