510(k) K251670

MAC 7 Resting ECG Analysis System by Ge Medical Systems Information Technologies, Inc. — Product Code DPS

K251670 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "MAC 7 Resting ECG Analysis System". The FDA issued a decision of Substantially Equivalent on January 26, 2026. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.