510(k) K002115

A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS by A&D Engineering, Inc. — Product Code DXN

K002115 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS". The FDA issued a decision of Substantially Equivalent on July 25, 2000. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.