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

    MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310

    K Number: K061959 · Decision Aug 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    42

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    Basic Information

    Device Name
    MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
    K Number
    K061959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mytech Technology Co., Ltd.
    Date Received
    July 11, 2006
    Decision Date
    August 22, 2006
    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 Mytech Technology Co., Ltd.

    K Number Device Name
    K041228 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
    K030221 MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR
    K030561 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A