The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto 5 Superpower.
| Device ID | K213733 |
| 510k Number | K213733 |
| Device Name: | Ponto 5 SuperPower |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Oticon Medical AB Datavagen 37B Askim, SE Se-436 32 |
| Contact | Anja Ravn |
| Correspondent | Anja Ravn Oticon Medical AB Datavagen 37B Askim, SE Se-436 32 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-26 |
| Decision Date | 2021-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712149026982 | K213733 | 000 |
| 05712149026975 | K213733 | 000 |
| 05712149026555 | K213733 | 000 |
| 05712149026548 | K213733 | 000 |
| 05712149026531 | K213733 | 000 |
| 05712149026524 | K213733 | 000 |
| 05712149026517 | K213733 | 000 |
| 05712149026500 | K213733 | 000 |
| 05712149026494 | K213733 | 000 |