BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE

    K Number: K903771 · Decision Feb 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    230
    Review Days
    183

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    Basic Information

    Device Name
    HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
    K Number
    K903771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hewlett-Packard Co.
    Date Received
    August 20, 1990
    Decision Date
    February 19, 1991
    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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