BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor

    K Number: K170196 · Decision May 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    2
    Review Days
    114

    Basic Information

    Device Name
    A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
    K Number
    K170196
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A&D Company, Ltd.
    Date Received
    January 23, 2017
    Decision Date
    May 17, 2017
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by A&D Company, Ltd.

    K Number Device Name
    K173191 A&D Medical Blood Pressure Monitors