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

    ATS BLOOD RECOVERY BAG

    K Number: K883663 · Decision Sep 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    63
    Review Days
    35

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    Basic Information

    Device Name
    ATS BLOOD RECOVERY BAG
    K Number
    K883663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Atrium Medical Corp.
    Date Received
    August 26, 1988
    Decision Date
    September 30, 1988
    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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