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

    EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

    K Number: K100709 · Decision Dec 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    174
    Applicant Total
    77
    Review Days
    270

    Basic Information

    Device Name
    EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
    K Number
    K100709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EDWARDS LIFESCIENCES, LLC.
    Date Received
    March 12, 2010
    Decision Date
    December 7, 2010
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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