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510(k) Data Aggregation

    K Number
    K161844
    Device Name
    Matrix Pre-Treatment Controller
    Manufacturer
    Date Cleared
    2016-12-13

    (161 days)

    Product Code
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    BETTER WATER, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Matrix Pre-Treatment Controller is designed to safely and effectively provide monitoring and control of the pre-treatment components for water purification for dialysis applications. These pre-treatment components include media-tanks with controllable valves (for example, but not limited to: multimedia depth filters, filox media filters, water softeners, dealkalizers, organic scavengers, and carbon media filters), city booster pump, ultra-violet light dump valve, blend-valve, and the main water shut-off valve. It monitors water pressures, water temperature, Delta-P pressure between two points), water flowrate, water pH, empty bed contact time for carbon media filters, and the status of the media-tanks' valve cycles. This operational data is displayed on a HMI-touch screen along with trends, alarms, and events. It controls the regeneration and backwash cycles for media tanks, the city booster pump, the ultra-violet light dump valve for cooling purposes, the blend-valve to allow greater flow during backwash and regeneration, and the main water shut-off valve if a leak is detected. Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility.
    Device Description
    The Matrix Pre-Treatment Controller is a control box which provides control and monitoring of the pretreatment system. This includes the city water entering into the water treatment system, as well as the various pre-treatment components providing filtration and treatment. The unique feature of this Controller is the digital touch-screen (HMI – human machine interface, OIT - operator interface terminal). This displays various system pressures, water temperature, alarms, and messages related to the pre-treatment system, and allows for touch-screen control and setup of the pre-treatment components.
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