Clearance Summary
RIONET HEARING AID received FDA 510(k) clearance under submission number K802812, sponsored by Kindel & Anderson. 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 1980-11-26.
- Submission: K802812
- Applicant / Sponsor: Kindel & Anderson
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3330
- Decision date: 1980-11-26
Classification & Regulation
This clearance is catalogued under FDA product code KHL and 21 CFR 874.3330, within the Ear, Nose, Throat review panel as a Class II device.