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 | K121228 |
| 510k Number | K121228 |
| Device Name: | PONTO BONE ANCHORED HEARING SYSTEM |
| Classification | Hearing Aid, Bone Conduction, Implanted |
| Applicant | OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Contact | Karolin Isberg Jernby |
| Correspondent | Karolin Isberg Jernby OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-23 |
| Decision Date | 2012-09-07 |
| Summary: | summary |