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510(k) Data Aggregation

    K Number
    K112331
    Device Name
    BIOPURE PORTABLE RO SYSTEMS
    Manufacturer
    ARION WATER, INC.
    Date Cleared
    2012-07-05

    (328 days)

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

    ARION WATER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and RD62:2006/A1:2009) and the CMS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics.
    Device Description
    The Arion Dialysis Water System is comprised of water purification equipment used to purify water for hemodialysis.
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