BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇮 Slovenia

    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

    K Number: K213730 · Decision Apr 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
    K Number
    K213730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
    Date Received
    November 26, 2021
    Decision Date
    April 21, 2022
    Product Code
    JOM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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    Other Clearances by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

    K Number Device Name
    K223670 MESI mTablet ECG Diagnostic System, MESI mTablet ECG