Clearance Summary
TINNITUS SOUNDSUPPORT received FDA 510(k) clearance under submission number K133308, sponsored by Oticon 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 2014-03-18.
- Submission: K133308
- Applicant / Sponsor: Oticon A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2014-03-18
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.