Clearance Summary
RIONET HEARING AID HB-52AS received FDA 510(k) clearance under submission number K915319, sponsored by Rion Co. Ltd. Dba Rion Acoustic Device. 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 1992-01-09.
- Submission: K915319
- Applicant / Sponsor: Rion Co. Ltd. Dba Rion Acoustic Device
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1992-01-09
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.