Clearance Summary
DOCE ALL-IN-THE-EAR AID received FDA 510(k) clearance under submission number K822817, sponsored by Fidelty Hearing Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1983-01-18.
- Submission: K822817
- Applicant / Sponsor: Fidelty Hearing Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5160
- Decision date: 1983-01-18
Classification & Regulation
This clearance is catalogued under FDA product code FSD and 21 CFR 880.5160, within the General Hospital review panel as a Class I device.