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510(k) Data Aggregation

    K Number
    K024228
    Device Name
    RX300 OXYGEN ANALYZER
    Manufacturer
    TELEDYNE ANALYTICAL INSTRUMENTS
    Date Cleared
    2003-07-17

    (206 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RX300 OXYGEN ANALYZER

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

    The AX300 is intended to accurately measure (spot check) and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of a medical device, the AX300 Oxygen Analyzer. It details the regulatory classification and general information about marketing the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details related to proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a scientific study report.

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