The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha 4 Sound Processor.
| Device ID | K132278 |
| 510k Number | K132278 |
| Device Name: | COCHLEAR BAHA 4 SOUND PROCESSOR |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | COCHLEAR AMERICAS 13059 EAST PEAKVIEW AVENUE Centennial, CO 80111 |
| Contact | Sean Bundy |
| Correspondent | Sean Bundy COCHLEAR AMERICAS 13059 EAST PEAKVIEW AVENUE 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 | 2013-07-23 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502026444 | K132278 | 000 |
| 09321502026437 | K132278 | 000 |
| 09321502026420 | K132278 | 000 |
| 09321502026413 | K132278 | 000 |
| 09321502026406 | K132278 | 000 |
| 09321502026390 | K132278 | 000 |
| 09321502074124 | K132278 | 000 |
| 09321502074117 | K132278 | 000 |