The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto Bone Anchored Hearing System, Mono Surgery Kit.
| Device ID | K203807 |
| 510k Number | K203807 |
| Device Name: | Ponto Bone Anchored Hearing System, MONO Surgery Kit |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | Oticon Medical AB Datavagen 37B Askim, SE Se-436 32 |
| Contact | Carolina Anker Wessling |
| Correspondent | Carolina Anker Wessling Oticon Medical AB Datavagen 37B Askim, SE Se-436 32 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712149026302 | K203807 | 000 |