510(k) K153450

Microlife Upper Arm Automatic Digital Blood Pressure Monitor by Microlife Intellectual Property GmbH — Product Code DXN

K153450 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on December 16, 2015. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Intellectual Property GmbH has at least 10 other 510(k) clearances on record.