Clearance Summary
TRANQUIL TRI-BTE received FDA 510(k) clearance under submission number K061459, sponsored by General Hearing Instruments, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2006-06-30.
- Submission: K061459
- Applicant / Sponsor: General Hearing Instruments, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2006-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KLW and 21 CFR 874.3400, within the Ear, Nose, Throat review panel as a Class II device.