Clearance Summary
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON received FDA 510(k) clearance under submission number K121793, 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 2012-11-01.
- Submission: K121793
- Applicant / Sponsor: Audifon-USA, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3302
- Decision date: 2012-11-01
Classification & Regulation
This clearance is catalogued under FDA product code LXB and 21 CFR 874.3302, within the Ear, Nose, Throat review panel as a Class II device.