510(k) K072060

QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V by Nihon Kohden America, Inc. — Product Code DPS

K072060 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V". The FDA issued a decision of Substantially Equivalent on August 17, 2007. 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.