Clearance Summary
HORTMANN AMDIS-OAE OAE ANALYZER received FDA 510(k) clearance under submission number K980505, sponsored by Hortmann AG. 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 1998-04-07.
- Submission: K980505
- Applicant / Sponsor: Hortmann AG
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1998-04-07
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.