Clearance Summary
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC received FDA 510(k) clearance under submission number K971399, sponsored by General Hearing Instruments, 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 1997-06-13.
- Submission: K971399
- Applicant / Sponsor: General Hearing Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1997-06-13
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.