The following data is part of a premarket notification filed by Wsaud A/s with the FDA for Vibe Sf Self-fitting Hearing Aid.
| Device ID | K220403 |
| 510k Number | K220403 |
| Device Name: | Vibe SF Self-Fitting Hearing Aid |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | WSAUD A/S Nymollevej 6 Lynge, DK 3540 |
| Contact | Kristine Klitgaard Pedersen |
| Correspondent | John Smith Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-08-12 |