Clearance Summary
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID received FDA 510(k) clearance under submission number K897023, sponsored by Audina Hearing Instrument. 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 1990-03-16.
- Submission: K897023
- Applicant / Sponsor: Audina Hearing Instrument
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1990-03-16
Classification & Regulation
This clearance is catalogued under FDA product code LRB and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.