510(k) K080337

MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D by Microlife Corp. — Product Code DXN

K080337 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D". The FDA issued a decision of Substantially Equivalent on May 13, 2008. 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.