Clearance Summary
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES received FDA 510(k) clearance under submission number K080366, sponsored by Zefon Intl.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-06-09.
- Submission: K080366
- Applicant / Sponsor: Zefon Intl.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2008-06-09
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.