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510(k) Data Aggregation

    K Number
    K971129
    Device Name
    OXYPURE PORTABLE OXYGEN GENERATOR
    Manufacturer
    ARBOR RESEARCH CORP.
    Date Cleared
    1997-06-24

    (89 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

    Oxygen generated by a portable oxygen generator is supplemental and should not be considered life-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician.

    This device is intended for home use, in patients requiring supplemental oxygen for the palliative or therapeutic treatment of a variety of respiratory diseases, including emphysema, chronic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis.

    Federal law restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician.

    This unit is not to be used for or with any life-supporting applications. Geriatic, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.

    Device Description

    OxyPure Portable Oxygen Generator

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called the "OxyPure Portable Oxygen Generator." This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

    The letter explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed before specific dates. This type of regulatory clearance typically relies on demonstrating equivalence to existing legally marketed devices, rather than comprehensive studies with detailed performance metrics and ground truth establishment as would be required for novel or high-risk devices.

    Therefore, I cannot fulfill your request using the provided information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed analysis of performance metrics from a specific study.

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