510(k) K173226

CardiMax Electrocardiograph by Fukuda Denshi USA, Inc. — Product Code DPS

K173226 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "CardiMax Electrocardiograph". The FDA issued a decision of Substantially Equivalent on April 16, 2018. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.