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

    DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862

    K Number: K040309 · Decision Feb 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    21
    Review Days
    15

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    Basic Information

    Device Name
    DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
    K Number
    K040309
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Seimitsu Sokki Co., Ltd.
    Date Received
    February 9, 2004
    Decision Date
    February 24, 2004
    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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