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    K Number
    K131611
    Device Name
    FRESENIUS DRY ACID DISSOLUTION UNITS
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Date Cleared
    2013-08-29

    (87 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRESENIUS DRY ACID DISSOLUTION UNITS

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

    The Fresenius Medical Care Dry Acid Dissolution Unit mixes Fresenius Medical Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a medical device (Fresenius Dry Acid Dissolution Unit) and outlines regulatory information, but it does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report.

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