510(k) K072217

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M by Nihon Kohden America, Inc. — Product Code DPS

K072217 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M". The FDA issued a decision of Substantially Equivalent on August 30, 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.