Clearance Summary
PHONAK TINNITUS BALANCE received FDA 510(k) clearance under submission number K123450, sponsored by Phonak, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2013-02-11.
- Submission: K123450
- Applicant / Sponsor: Phonak, LLC
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2013-02-11
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.