Clearance Summary
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM received FDA 510(k) clearance under submission number K884371, sponsored by Madsen Electronics (Canada) , Ltd.. 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 1989-02-13.
- Submission: K884371
- Applicant / Sponsor: Madsen Electronics (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3310
- Decision date: 1989-02-13
Classification & Regulation
This clearance is catalogued under FDA product code ETW and 21 CFR 874.3310, within the Ear, Nose, Throat review panel as a Class II device.