BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ILLUMINATOR III

    K Number: K922278 · Decision Mar 4, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    36
    Applicant Total
    10
    Review Days
    293

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    Basic Information

    Device Name
    ILLUMINATOR III
    K Number
    K922278
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6320
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Illumination, Inc.
    Date Received
    May 15, 1992
    Decision Date
    March 4, 1993
    Product Code
    KZF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KZF Device, Medical Examination, Ac Powered

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    K922280 ILLUMINATOR VII MINI/LUM LIGHT
    K922277 ILLUMINATOR II
    K922279 ILLUMINATOR IV MINOR SURGERY LIGHT