The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha Implant System.
| Device ID | K121317 |
| 510k Number | K121317 |
| Device Name: | COCHLEAR BAHA IMPLANT SYSTEM |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| 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 | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502033435 | K121317 | 000 |
| 09321502022705 | K121317 | 000 |
| 09321502022712 | K121317 | 000 |
| 09321502022729 | K121317 | 000 |
| 09321502022736 | K121317 | 000 |
| 09321502022743 | K121317 | 000 |
| 09321502022750 | K121317 | 000 |
| 09321502022767 | K121317 | 000 |
| 09321502025294 | K121317 | 000 |
| 09321502022699 | K121317 | 000 |