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

    Raycell Mk2

    K Number: K161324 · Decision Aug 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    4
    Review Days
    93

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    Basic Information

    Device Name
    Raycell Mk2
    K Number
    K161324
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Best Theratronics Limited
    Date Received
    May 11, 2016
    Decision Date
    August 12, 2016
    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 Best Theratronics Limited

    K Number Device Name
    K181737 Raycell MK1
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