Clearance Summary
HF MEGA EAR received FDA 510(k) clearance under submission number K960567, sponsored by Maxi-Aids, Inc.. 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 1996-10-16.
- Submission: K960567
- Applicant / Sponsor: Maxi-Aids, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3320
- Decision date: 1996-10-16
Classification & Regulation
This clearance is catalogued under FDA product code EPF and 21 CFR 874.3320, within the Ear, Nose, Throat review panel as a Class II device.