Clearance Summary
WIDEXLINK IN CLEAR SERIES HEARING AIDS received FDA 510(k) clearance under submission number DEN100025, sponsored by Office Research IN Clinical Amplifiction. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2011-03-31.
- Submission: DEN100025
- Applicant / Sponsor: Office Research IN Clinical Amplifiction
- Clearance pathway: Post-NSE
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3305
- Decision date: 2011-03-31
Classification & Regulation
This clearance is catalogued under FDA product code OSM and 21 CFR 874.3305, within the Ear, Nose, Throat review panel as a Class II device.