Clearance Summary
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM received FDA 510(k) clearance under submission number K080853, sponsored by Genexel-Sein, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-02-20.
- Submission: K080853
- Applicant / Sponsor: Genexel-Sein, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2009-02-20
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.