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

    Globalcare Blood Pressure Monitor (GUS610)

    K Number: K250136 · Decision Apr 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    Globalcare Blood Pressure Monitor (GUS610)
    K Number
    K250136
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Globalcare Medical Technology Co., Ltd.
    Date Received
    January 17, 2025
    Decision Date
    April 8, 2025
    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
    K253896 TENS/EMS device (GUSE01)
    K222160 GUS610 Blood pressure monitor
    K192633 GUS831 Compressor Nebulizer
    K192609 Globalcare Blood Pressure Monitor