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    K Number
    K020542
    Device Name
    DAYTRIPPER DIALYSATE WARMER
    Manufacturer
    STICKMAN INDUSTRIES INC.
    Date Cleared
    2002-09-27

    (220 days)

    Product Code
    MLW
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DAYTRIPPER DIALYSATE WARMER

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

    The Daytripper CAPD travel warmer carrying case's intended use is to warm a single bag of peritoneal dialysate (if below 37°C) up to body temperature and maintain it until required for an exchange procedure. The Daytripper also serves as a carrying case and insulator for the dialysate.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Daytripper CAPD Warmer." It states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance or the other requested study details based on the provided text. The document is strictly an FDA clearance letter and does not include the technical study report.

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