510(k) K201046

Automated ankle brachial pressure index measuring device, MESI mTABLET system by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. — Product Code JOM

K201046 is an FDA 510(k) premarket notification submitted by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. for the device "Automated ankle brachial pressure index measuring device, MESI mTABLET system". The FDA issued a decision of Substantially Equivalent on December 11, 2020. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. has at least 1 other 510(k) clearance on record.