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

    MI-15 EXAM SURGICAL LIGHT

    K Number: K930897 · Decision Jun 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    28
    Applicant Total
    10
    Review Days
    123

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    Basic Information

    Device Name
    MI-15 EXAM SURGICAL LIGHT
    K Number
    K930897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Illumination, Inc.
    Date Received
    February 22, 1993
    Decision Date
    June 25, 1993
    Product Code
    FTD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTD Lamp, Surgical

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    Other Clearances by Medical Illumination, Inc.

    K Number Device Name
    K931026 MI-5 DIAGNOSTIC LIGHT
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    K922278 ILLUMINATOR III
    K922282 ILLUMINATOR VIII ULTRA/SPOT
    K922281 ILLUMINATOR VII MINI/SPOT LIGHT
    K922280 ILLUMINATOR VII MINI/LUM LIGHT
    K922277 ILLUMINATOR II
    K922279 ILLUMINATOR IV MINOR SURGERY LIGHT