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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    WRISTWATCH BLOOD PRESSURE MONITOR A46

    K Number: K010498 · Decision Mar 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    27

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    Basic Information

    Device Name
    WRISTWATCH BLOOD PRESSURE MONITOR A46
    K Number
    K010498
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rossmax Internationl , Ltd.
    Date Received
    February 21, 2001
    Decision Date
    March 20, 2001
    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 Rossmax Internationl , Ltd.

    K Number Device Name
    K053006 ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
    K020897 ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
    K010190 WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43