510(k) K083078

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 by Quanta Computer, Inc. — Product Code DXN

K083078 is an FDA 510(k) premarket notification submitted by Quanta Computer, Inc. for the device "QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200". The FDA issued a decision of Substantially Equivalent on November 26, 2008. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Quanta Computer, Inc. has at least 4 other 510(k) clearances on record.