K121317 is an FDA 510(k) clearance for the COCHLEAR BAHA IMPLANT SYSTEM. This device is classified as a Hearing Aid, Bone Conduction, Implanted (Class II - Special Controls, product code MAH).
Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on October 12, 2012, 163 days after receiving the submission on May 2, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K121317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2012 |
| Decision Date | October 12, 2012 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MAH — Hearing Aid, Bone Conduction, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |