Clearance Summary
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S received FDA 510(k) clearance under submission number K130417, sponsored by Audifon-USA, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2013-09-12.
- Submission: K130417
- Applicant / Sponsor: Audifon-USA, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2013-09-12
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.