510(k) K013485

MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 by Microlife Corp. — Product Code DXN

K013485 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1". The FDA issued a decision of Substantially Equivalent on January 17, 2002. 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.