K121228 is an FDA 510(k) clearance for the PONTO BONE ANCHORED HEARING SYSTEM. This device is classified as a Hearing Aid, Bone Conduction, Implanted (Class II - Special Controls, product code MAH).
Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on September 7, 2012, 137 days after receiving the submission on April 23, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K121228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2012 |
| Decision Date | September 07, 2012 |
| Days to Decision | 137 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 |