BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LUMOS, MODEL R 72B

    K Number: K093596 · Decision Jan 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    53

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    Basic Information

    Device Name
    LUMOS, MODEL R 72B
    K Number
    K093596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumos, Inc.
    Date Received
    November 20, 2009
    Decision Date
    January 12, 2010
    Product Code
    KPW
    Advisory Committee
    Radiology
    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
    KPW Device, Beam Limiting, X-Ray, Diagnostic

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