The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto Plus And Ponto Plus Power.
| Device ID | K132775 |
| 510k Number | K132775 |
| Device Name: | PONTO PLUS AND PONTO PLUS POWER |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Contact | Satu Hjartstam |
| Correspondent | Satu Hjartstam OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-05 |
| Decision Date | 2013-12-09 |
| Summary: | summary |