Clearance Summary
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE received FDA 510(k) clearance under submission number K112269, sponsored by OSTAR MEDITECH CORP.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-10-20.
- Submission: K112269
- Applicant / Sponsor: OSTAR MEDITECH CORP.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2011-10-20
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.