510(k) K213730

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. — Product Code JOM

K213730 is an FDA 510(k) premarket notification submitted by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. for the device "MESI mTABLET TBI diagnostic system, MESI mTABLET TBI". The FDA issued a decision of Substantially Equivalent on April 21, 2022. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. has at least 1 other 510(k) clearance on record.