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

    IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2

    K Number: K812355 · Decision Sep 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    8
    Review Days
    21

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    Basic Information

    Device Name
    IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2
    K Number
    K812355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Business Machines
    Date Received
    August 19, 1981
    Decision Date
    September 9, 1981
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HE
    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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