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

    INTRAOPERATIVE AUTOTRANSFUSION SYS

    K Number: K831557 · Decision Aug 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    10
    Review Days
    100

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    Basic Information

    Device Name
    INTRAOPERATIVE AUTOTRANSFUSION SYS
    K Number
    K831557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Thoratec Laboratories Corp.
    Date Received
    May 16, 1983
    Decision Date
    August 24, 1983
    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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