510(k) K012013

LIFESOURCE MODELS UA-787, UA 787PC, UA-787T by A&D Engineering, Inc. — Product Code DXN

K012013 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "LIFESOURCE MODELS UA-787, UA 787PC, UA-787T". The FDA issued a decision of Substantially Equivalent on July 13, 2001. 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.