Clearance Summary
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES received FDA 510(k) clearance under submission number K092514, sponsored by Hangzhou Hua'An Medical & Health Instruments Co.,. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-12-04.
- Submission: K092514
- Applicant / Sponsor: Hangzhou Hua'An Medical & Health Instruments Co.,
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2009-12-04
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.