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

    RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

    K Number: K082921 · Decision Feb 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    139

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    Basic Information

    Device Name
    RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
    K Number
    K082921
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rad Source Technologies, Inc.
    Date Received
    October 1, 2008
    Decision Date
    February 17, 2009
    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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