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510(k) Data Aggregation

    K Number
    K023120
    Device Name
    OXYCON MOBILE
    Manufacturer
    ERICH JAEGER GMBH
    Date Cleared
    2003-11-12

    (419 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K162515
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the Oxycon Mobile device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically associated with the rigorous testing and validation of a new AI/medical device. This type of letter is an approval for marketing based on substantial equivalence, not a detailed technical report of the device's performance or a study proving its meeting of specific acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter.

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