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

    MI-750 PROCEDURAL/MINOR SURGICAL LIGHT

    K Number: K140812 · Decision Aug 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    128

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    Basic Information

    Device Name
    MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
    K Number
    K140812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Illumination International, Inc.
    Date Received
    April 1, 2014
    Decision Date
    August 7, 2014
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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    Other Clearances by Medical Illumination International, Inc.

    K Number Device Name
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    K003489 NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8