The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto 4.
| Device ID | K190540 |
| 510k Number | K190540 |
| Device Name: | Ponto 4 |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | Oticon Medical AB Datavagen 37 B Askim, SE Se-436 32 |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen Oticon Medical AB Datavagen 37 B Askim, SE Se-436 32 |
| Product Code | LXB |
| Subsequent Product Code | ESD |
| Subsequent Product Code | MAH |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712149025411 | K190540 | 000 |
| 05712149025404 | K190540 | 000 |
| 05712149025398 | K190540 | 000 |
| 05712149025381 | K190540 | 000 |
| 05712149025374 | K190540 | 000 |
| 05712149025367 | K190540 | 000 |
| 05712149025350 | K190540 | 000 |
| 05712149025329 | K190540 | 000 |
| 05712149025312 | K190540 | 000 |