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

    PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037

    K Number: K042818 · Decision Jan 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
    K Number
    K042818
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Matsushita Electric Works, Ltd.
    Date Received
    October 12, 2004
    Decision Date
    January 27, 2005
    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 Matsushita Electric Works, Ltd.

    K Number Device Name
    K033894 PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032