Clearance Summary
IE-ZEN (IN CLEAR SERIES HEARING AID) received FDA 510(k) clearance under submission number K110973, sponsored by Widex USA. 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 2011-05-05.
- Submission: K110973
- Applicant / Sponsor: Widex USA
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2011-05-05
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.