510(k) K010828

DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP by A&D Engineering, Inc. — Product Code DXN

K010828 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP". The FDA issued a decision of Substantially Equivalent on March 29, 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.