510(k) K052511

CARDIOFAX CE, MODEL ECG-1500 A by Nihon Kohden America, Inc. — Product Code DPS

K052511 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "CARDIOFAX CE, MODEL ECG-1500 A". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.