Clearance Summary
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER received FDA 510(k) clearance under submission number K964216, sponsored by Starkey Laboratories, 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 1996-12-06.
- Submission: K964216
- Applicant / Sponsor: Starkey Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 1996-12-06
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.