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510(k) Data Aggregation

    K Number
    K021352
    Date Cleared
    2002-08-01

    (94 days)

    Product Code
    Regulation Number
    876.5665
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dayton Water Systems' UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

    Device Description

    UltraPure Water Treatment System For Hemodialysis (modified) with Pretreatment PH Citric Acid Feed System

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

    The document is a letter from the FDA regarding a 510(k) premarket notification for a "UltraPure Water Treatment System For Hemodialysis". It discusses regulatory approval and general compliance requirements, but it does not include any performance data or study details.

    Therefore, I cannot fulfill your request to provide the table of acceptance criteria and the study details.

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