510(k) K001182

MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 by Microlife Corp. — Product Code DXN

K001182 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1". The FDA issued a decision of Substantially Equivalent on August 1, 2000. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Corp. has at least 10 other 510(k) clearances on record.