Clearance Summary
OPUS 2 - FULL CONCHA SERIES - ITE received FDA 510(k) clearance under submission number K974211, 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 1997-12-15.
- Submission: K974211
- Applicant / Sponsor: Bernafon-Maico, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1997-12-15
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.