K112053 is an FDA 510(k) clearance for the OBC 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 November 18, 2011, 122 days after receiving the submission on July 19, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K112053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2011 |
| Decision Date | November 18, 2011 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | MAH - Hearing Aid, Bone Conduction, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |