Clearance Summary
SOLACE SOUND GENERATORS received FDA 510(k) clearance under submission number K132965, sponsored by Amplisound Hearing Products & Services. 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 2014-03-25.
- Submission: K132965
- Applicant / Sponsor: Amplisound Hearing Products & Services
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2014-03-25
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.