Clearance Summary
INSERTION GAIN OPTIMIZER IGO-1000 received FDA 510(k) clearance under submission number K854535, 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 1986-02-20.
- Submission: K854535
- 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: 1986-02-20
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.