Clearance Summary
AURICAL HIT received FDA 510(k) clearance under submission number K122028, sponsored by Gn Otometrics. 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 2012-10-23.
- Submission: K122028
- Applicant / Sponsor: Gn Otometrics
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 2012-10-23
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.