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

    Automated ankle brachial pressure index measuring device

    K Number: K172655 · Decision Jan 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    Automated ankle brachial pressure index measuring device
    K Number
    K172655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
    Date Received
    September 5, 2017
    Decision Date
    January 11, 2018
    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 D.O.O.; Mesi, Development of Medical Devices, Ltd.

    K Number Device Name
    K201046 Automated ankle brachial pressure index measuring device, MESI mTABLET system