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510(k) Data Aggregation

    K Number
    K991569
    Device Name
    HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
    Manufacturer
    02 MARKETING GROUP, INC.
    Date Cleared
    1999-08-03

    (90 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "Home/Commercial Oxygen Unit by System O2™". The document is an FDA 510(k) clearance letter, which primarily addresses the substantial equivalence of the device to a legally marketed predicate device.

    The information you are requesting, such as specific performance metrics, study details, and ground truth establishment, is not present in this regulatory document.

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