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

    SURGICAL HEADLIGHT

    K Number: K061690 · Decision Sep 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    92

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    Basic Information

    Device Name
    SURGICAL HEADLIGHT
    K Number
    K061690
    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
    Gulf Medical Fiberoptics
    Date Received
    June 15, 2006
    Decision Date
    September 15, 2006
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

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