Clearance Summary
MAICO MA52 received FDA 510(k) clearance under submission number K971080, 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 1997-06-06.
- Submission: K971080
- 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: 1997-06-06
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.