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

    SORIN CONNECT DATA MANAGEMENT SYSTEM

    K Number: K131816 · Decision Jul 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    20
    Review Days
    33

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    Basic Information

    Device Name
    SORIN CONNECT DATA MANAGEMENT SYSTEM
    K Number
    K131816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Deutschland GmbH
    Date Received
    June 20, 2013
    Decision Date
    July 23, 2013
    Product Code
    DXJ
    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
    DXJ Display, Cathode-Ray Tube, Medical

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