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    K Number
    K981085
    Device Name
    GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
    Manufacturer
    GAMBRO HEALTHCARE
    Date Cleared
    1998-05-18

    (54 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes an FDA 510(k) clearance letter for the Gambro® Water Purification System. This document is a regulatory approval, not a scientific study describing device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, because these details are not present in the provided FDA clearance letter. This type of document confirms regulatory compliance and substantial equivalence, not the results of a detailed performance study.

    The document only states the "Indications for Use" for the device, which are:

    • Purification of water to be used for the dilution of dialysate concentrate by hemodialysis clinics.
    • Purification of water to be used in the reprocessing of dialyzers for reuse by hemodialysis clinics.
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