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

    AUTOLOG AUTOTRANSFUSION SYSTEM

    K Number: K093535 · Decision Mar 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    194
    Applicant Total
    84
    Review Days
    126

    Basic Information

    Device Name
    AUTOLOG AUTOTRANSFUSION SYSTEM
    K Number
    K093535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC INC.
    Date Received
    November 16, 2009
    Decision Date
    March 22, 2010
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    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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