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

    TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR

    K Number: K113083 · Decision Jan 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    93

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    Basic Information

    Device Name
    TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
    K Number
    K113083
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Truly Instrument Co., Ltd.
    Date Received
    October 18, 2011
    Decision Date
    January 19, 2012
    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 Truly Instrument Co., Ltd.

    K Number Device Name
    K113085 TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
    K091434 TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
    K091415 TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M