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510(k) Data Aggregation

    K Number
    K081206
    Device Name
    HOMELOX
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2008-07-28

    (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 HomeLox is intended to create and store liquid oxygen in a patient's home, so that a patient will be able to fill their liquid portable unit and ambulate. The device is intended only to be a LOX reservoir for filling a portable unit and is not life supporting nor life sustaining.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (HomeLox Portable Oxygen Generator), but it does not include details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. The letter primarily focuses on the regulatory clearance of the device based on substantial equivalence to legally marketed predicates.

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