The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha 3 Power Sound Processor.
| Device ID | K110996 |
| 510k Number | K110996 |
| Device Name: | BAHA 3 POWER SOUND PROCESSOR |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial, CO 80111 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial, CO 80111 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502040228 | K110996 | 000 |
| 09321502040174 | K110996 | 000 |
| 09321502040181 | K110996 | 000 |
| 09321502040198 | K110996 | 000 |
| 09321502040204 | K110996 | 000 |
| 09321502040259 | K110996 | 000 |
| 09321502021135 | K110996 | 000 |
| 09321502021142 | K110996 | 000 |
| 09321502021159 | K110996 | 000 |
| 09321502021166 | K110996 | 000 |
| 09321502021173 | K110996 | 000 |
| 09321502021180 | K110996 | 000 |
| 09321502021197 | K110996 | 000 |
| 09321502021296 | K110996 | 000 |
| 09321502021302 | K110996 | 000 |
| 09321502040211 | K110996 | 000 |
| 09321502034654 | K110996 | 000 |