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

    MI-4 VARIABLE SPOT LIGHT

    K Number: K931646 · Decision Aug 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    36
    Applicant Total
    10
    Review Days
    139

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    Basic Information

    Device Name
    MI-4 VARIABLE SPOT LIGHT
    K Number
    K931646
    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
    April 2, 1993
    Decision Date
    August 19, 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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