Clearance Summary
Vibe SF Self-Fitting Hearing Aid received FDA 510(k) clearance under submission number K220403, sponsored by Wsaud A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2022-08-12.
- Submission: K220403
- Applicant / Sponsor: Wsaud A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3325
- Decision date: 2022-08-12
Classification & Regulation
This clearance is catalogued under FDA product code QDD and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.