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

    ENSITE SYSTEM

    K Number: K033211 · Decision Oct 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    ENSITE SYSTEM
    K Number
    K033211
    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
    October 3, 2003
    Decision Date
    October 30, 2003
    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
    K042493 ENSITE SYSTEM, MODEL EE3000
    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