Clearance Summary
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 received FDA 510(k) clearance under submission number K883478, 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 1988-11-17.
- Submission: K883478
- Applicant / Sponsor: Madsen Electronics (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1988-11-17
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.