Clearance Summary
ZODIAC 901 MIDDLE-EAR ANALYZER received FDA 510(k) clearance under submission number K910247, 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 1991-06-19.
- Submission: K910247
- Applicant / Sponsor: Madsen Electronics (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 1991-06-19
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.