The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto 5 Mini.
| Device ID | K211640 |
| 510k Number | K211640 |
| Device Name: | Ponto 5 Mini |
| 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 | 2021-05-27 |
| Decision Date | 2021-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712149026814 | K211640 | 000 |
| 05712149026807 | K211640 | 000 |
| 05712149026487 | K211640 | 000 |
| 05712149026470 | K211640 | 000 |
| 05712149026463 | K211640 | 000 |
| 05712149026456 | K211640 | 000 |
| 05712149026449 | K211640 | 000 |
| 05712149026432 | K211640 | 000 |
| 05712149026319 | K211640 | 000 |