Clearance Summary
Tinnitus Sound Generator Module received FDA 510(k) clearance under submission number K193303, sponsored by GN Hearing A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2020-02-20.
- Submission: K193303
- Applicant / Sponsor: GN Hearing A/S
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2020-02-20
Classification & Regulation
This clearance is catalogued under FDA product code KLW and 21 CFR 874.3400, within the Ear, Nose, Throat review panel as a Class II device.