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

    VISUM BLADE LED SURGICAL LIGHTING SYSTEM

    K Number: K132747 · Decision Dec 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    VISUM BLADE LED SURGICAL LIGHTING SYSTEM
    K Number
    K132747
    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
    Stryker Communications
    Date Received
    September 3, 2013
    Decision Date
    December 30, 2013
    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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