Clearance Summary
MAICO MA25 SERIES II WITH SPEECH received FDA 510(k) clearance under submission number K962275, sponsored by Bernafon-Maico, 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 1996-09-05.
- Submission: K962275
- Applicant / Sponsor: Bernafon-Maico, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1996-09-05
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.