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510(k) Data Aggregation

    K Number
    K022448
    Device Name
    WATER PURIFICATION SYSTEM
    Date Cleared
    2003-05-28

    (306 days)

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

    PURITY WATER COMPANY OF SAN ANTONIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Purify water used in hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water used in hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.
    Device Description
    Water purification system for hemodialysis. The typical customized system is configured with booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, deionization tanks, audible and visual alarms, and other components that purify water as a function of feed water quality and required capacity. The system product water complies with the AAMI Standard RD62:2001, Water Treatment Equipment for Hemodialysis Applications.
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