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510(k) Data Aggregation

    K Number
    K053464
    Device Name
    SERVICE MANAGER SM40SE
    Manufacturer
    CONMED INTEGRATED SYSTEMS, CANADA, ULC
    Date Cleared
    2006-06-06

    (175 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMED INTEGRATED SYSTEMS, CANADA, ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IV poles and smoke evacuation units. The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
    Device Description
    The SM40SE is a space management custom configured consoles into which a variety of medical devices are integrated including a surgical smoke evacuator. These SM40SE consoles are suspended from articulated ceiling pendant in general operating rooms, minimally invasive surgery suites and post-anaesthesia care units.
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