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

    autoLog IQ Autotransfusion System

    K Number: K181954 · Decision Aug 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    29
    Review Days
    30

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    Basic Information

    Device Name
    autoLog IQ Autotransfusion System
    K Number
    K181954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Perfusion Systems
    Date Received
    July 23, 2018
    Decision Date
    August 22, 2018
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    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
    CAC Apparatus, Autotransfusion

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