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

    CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K

    K Number: K101198 · Decision Aug 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
    K Number
    K101198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Computerized Screening, Inc.
    Date Received
    April 29, 2010
    Decision Date
    August 4, 2010
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Computerized Screening, Inc.

    K Number Device Name
    K093389 CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK