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

    ENSITE SYSTEM, MODEL EE3000

    K Number: K042493 · Decision Oct 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    8
    Review Days
    31

    Basic Information

    Device Name
    ENSITE SYSTEM, MODEL EE3000
    K Number
    K042493
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENDOCARDIAL SOLUTIONS, INC.
    Date Received
    September 14, 2004
    Decision Date
    October 15, 2004
    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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    Other Clearances by ENDOCARDIAL SOLUTIONS, INC.

    K Number Device Name
    K033211 ENSITE SYSTEM
    K030129 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
    K012926 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
    K001437 ENSITE 3000 SYSTEM, MODEL EE3000
    K993376 ENSTYLET MODELS EC0010, EC0020
    K992479 ENSITE 3000 SYSTEM
    K983456 ENSITE 3000 SYSTEM