510(k) K142288

MAC 800 Resting ECG Analysis System by Ge Medical Systems China Co., Ltd. — Product Code DPS

K142288 is an FDA 510(k) premarket notification submitted by Ge Medical Systems China Co., Ltd. for the device "MAC 800 Resting ECG Analysis System". The FDA issued a decision of Substantially Equivalent on December 3, 2014. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Ge Medical Systems China Co., Ltd. has at least 10 other 510(k) clearances on record.