The following data is part of a premarket notification filed by Sonitus Medical Inc with the FDA for Soundbite Hearing System By Sonitus.
| Device ID | K100649 |
| 510k Number | K100649 |
| Device Name: | SOUNDBITE HEARING SYSTEM BY SONITUS |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | SONITUS MEDICAL INC 25 HARTFORD AVE San Carlos, CA 94070 |
| Contact | Robert J Chin |
| Correspondent | Robert J Chin SONITUS MEDICAL INC 25 HARTFORD AVE San Carlos, CA 94070 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972667660313 | K100649 | 000 |