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

    L-LINEX-RAY FLUORESCENCE

    K Number: K911749 · Decision Aug 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    L-LINEX-RAY FLUORESCENCE
    K Number
    K911749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1220
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Montifore Medical Center
    Date Received
    April 18, 1991
    Decision Date
    August 20, 1991
    Product Code
    JAO
    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
    JAO Scanner, Fluorescent

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