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

    MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS

    K Number: K915766 · Decision Jul 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    1296

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    Basic Information

    Device Name
    MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
    K Number
    K915766
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J. L. Shepherd and Assoc.
    Date Received
    December 24, 1991
    Decision Date
    July 12, 1995
    Product Code
    MOT
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOT Irradiator, Blood To Prevent Graft Versus Host Disease

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    Other Clearances by J. L. Shepherd and Assoc.

    K Number Device Name
    K915767 MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS