BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    RAYCELL X-RAY BLOOD IRRADIATOR

    K Number: K051065 · Decision May 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    RAYCELL X-RAY BLOOD IRRADIATOR
    K Number
    K051065
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mds Nordion
    Date Received
    April 26, 2005
    Decision Date
    May 26, 2005
    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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