Clearance Summary
Tinnitus Sound Generator Module received FDA 510(k) clearance under submission number K150171, sponsored by Gn Resound 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 2015-05-14.
- Submission: K150171
- Applicant / Sponsor: Gn Resound A/S
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2015-05-14
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.