Clearance Summary
OTOFLEX 100 TYE 1012 received FDA 510(k) clearance under submission number K033645, sponsored by Gn Otometrics A/S. 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 2004-03-31.
- Submission: K033645
- Applicant / Sponsor: Gn Otometrics A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 2004-03-31
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.