510(k) K223670

MESI mTablet ECG Diagnostic System, MESI mTablet ECG by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. — Product Code DPS

K223670 is an FDA 510(k) premarket notification submitted by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. for the device "MESI mTablet ECG Diagnostic System, MESI mTablet ECG". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. has at least 1 other 510(k) clearance on record.