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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Globalcare Blood Pressure Monitor

    K Number: K192609 · Decision Apr 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    214

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    Basic Information

    Device Name
    Globalcare Blood Pressure Monitor
    K Number
    K192609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Globalcare Medical Technology Co., Ltd.
    Date Received
    September 20, 2019
    Decision Date
    April 21, 2020
    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 Globalcare Medical Technology Co., Ltd.

    K Number Device Name
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