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

    MODIFICATION TO ENSITE SYSTEM, MODEL EE3000

    K Number: K060954 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
    K Number
    K060954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St. Jude Medical, Inc.-Endocardial Solutions
    Date Received
    April 7, 2006
    Decision Date
    April 21, 2006
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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