510(k) K092514

UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES by Hangzhou Hua'An Medical & Health Instruments Co., — Product Code DXN

K092514 is an FDA 510(k) premarket notification submitted by Hangzhou Hua'An Medical & Health Instruments Co., for the device "UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES". The FDA issued a decision of Substantially Equivalent on Dec 4, 2009. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Hangzhou Hua'An Medical & Health Instruments Co., has 9 other 510(k) clearances on record.