The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto Bone Anchored Hearing System.
| Device ID | K152820 |
| 510k Number | K152820 |
| Device Name: | Ponto Bone Anchored Hearing System |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | OTICON MEDICAL AB DATAVAGEN 37B Askim, SE 436 32 |
| Contact | Carolina Anker Wessling |
| Correspondent | Carolina Anker Wessling OTICON MEDICAL AB DATAVAGEN 37B Askim, SE 436 32 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-01-22 |
| Summary: | summary |