510(k) K024077

DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR by Zewa, Inc. — Product Code DXN

K024077 is an FDA 510(k) premarket notification submitted by Zewa, Inc. for the device "DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR". The FDA issued a decision of Substantially Equivalent on March 10, 2003. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Zewa, Inc. has at least 3 other 510(k) clearances on record.