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

    ABPM7100

    K Number: K140928 · Decision Sep 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    5
    Review Days
    157

    Basic Information

    Device Name
    ABPM7100
    K Number
    K140928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.E.M. GMBH
    Date Received
    April 11, 2014
    Decision Date
    September 15, 2014
    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 I.E.M. GMBH

    K Number Device Name
    K153557 ABPM 7100, Hypertension Management Software
    K110603 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
    K072446 MOBIL-O-GRAPH NG 24 H ABP-CONTROL
    K041313 STABIL-O-GRAPH