510(k) K112521

FUKUDA DENSHI VASERA MODEL VS-1500 by Fukuda Denshi USA, Inc. — Product Code DXN

K112521 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI VASERA MODEL VS-1500". The FDA issued a decision of Substantially Equivalent on December 21, 2011. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.