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510(k) Data Aggregation

    K Number
    K043207
    Device Name
    OZONE GENERATOR
    Manufacturer
    GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES
    Date Cleared
    2005-11-04

    (350 days)

    Product Code
    NII, FIN
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GE INFRASTRUCTURE WATER **& PROCESS TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
    Device Description
    The Ozone Generating System attaches to the Solution Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
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