Clearance Summary
KENZ 80Z MARK II received FDA 510(k) clearance under submission number K843731, sponsored by Suzuken Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-07-11.
- Submission: K843731
- Applicant / Sponsor: Suzuken Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1985-07-11
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.