510(k) K073397

MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) by Microlife Corp. — Product Code DXN

K073397 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)". The FDA issued a decision of Substantially Equivalent on December 20, 2007. 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.