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

    RadGil2

    K Number: K201177 · Decision Aug 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    RadGil2
    K Number
    K201177
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R3 X-Ray L.L.C
    Date Received
    May 1, 2020
    Decision Date
    August 17, 2020
    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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