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510(k) Data Aggregation

    K Number
    K971545
    Device Name
    PROTEGE LIQUID OXYGEN SYSTEM
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1997-07-25

    (88 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROTEGE LIQUID OXYGEN SYSTEM

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

    The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.

    Device Description

    Portable Liquid Oxygen System BYJ

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Protégé Liquid Oxygen System". This document
    DOES NOT CONTAIN
    information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of document merely grants market clearance based on substantial equivalence to a predicate device, it does not detail the specifics of performance testing.

    Therefore, I cannot fulfill your request using the provided text.

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