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

    MD308H DIGITAL/MB351H AUTO-BP MONITOR

    K Number: K842200 · Decision Oct 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    10
    Review Days
    142

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    Basic Information

    Device Name
    MD308H DIGITAL/MB351H AUTO-BP MONITOR
    K Number
    K842200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sharp Electronics Corp.
    Date Received
    June 4, 1984
    Decision Date
    October 24, 1984
    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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