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510(k) Data Aggregation

    K Number
    K990037
    Device Name
    NEPTUNE WASTE MANAGEMENT SYSTEM
    Manufacturer
    AMERICAN IMMUNO TECH
    Date Cleared
    1999-08-24

    (230 days)

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

    AMERICAN IMMUNO TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neptune Waste Management System is intended to be used in the Operating Room, Pathology, Surgical Centers and Doctor's Offices to collect and sterilize surgical fluid waste as well as evacuate smoke generated from electro-cautery or laser devices.
    Device Description
    The Neptune Waste Management System (hereafter referred to as the Neptune System) collects and evacuates surgical fluid waste as well as smoke generated from lasers and electro-cautery devices. The Neptune System also provides its own independent suction capability, in lieu of wall suction, and can electronically measure fluid volume output. The Neptune System is a closed system. It replaces vacuum canisters and reduces the solid waste that is generated by the use of suction canisters. The Neptune System includes two pieces of equipment; a Rover unit and the Docking Station. The Rover has an accessory, the Infrared Transmitter, to actuate the Rover's smoke evacuation capability. The Rover incorporates a 20 liter basin for the collection of fluid waste and can evacuate smoke generated from electro-cautery and laser devices through a variety of disposable tubing kits. The Rover's basin features volume markings and a built-in electronic volume meter. The Rover's manifold can handle up to four suction lines. The Rover features a vacuum blower motor that is used to evacuate smoke. The vacuum blower motor can also be used as an independent source of suction. The Docking Station's control panel incorporates three switches that allow for simple user interaction and control of the process. A series of voice alarms provides user instructions for ease of use. The Infrared Transmitter attaches onto the power cord of a laser or an electrocautery device. When a laser or electro-cautery device is turned on, an infrared signal is sent that activates the Rover's smoke evacuation capability.
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