K203807 is an FDA 510(k) clearance for the Ponto Bone Anchored Hearing System, MONO Surgery Kit. 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 March 3, 2021, 65 days after receiving the submission on December 28, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K203807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2020 |
| Decision Date | March 03, 2021 |
| Days to Decision | 65 days |
| Submission Type | Special |
| 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 |