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

    EDAC QUANTIFIER

    K Number: K071231 · Decision May 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    EDAC QUANTIFIER
    K Number
    K071231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luna Innovations, Inc.
    Date Received
    May 3, 2007
    Decision Date
    May 17, 2007
    Product Code
    KRL
    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
    KRL Detector, Bubble, Cardiopulmonary Bypass

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