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510(k) Data Aggregation

    K Number
    K131023
    Device Name
    THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
    Manufacturer
    MEDICAL PRODUCTS, LLC
    Date Cleared
    2013-10-11

    (182 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for a device called "TheraFlow Single and Dual Lumen Regulation" (K131023).

    This letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment methods.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and device performance based on the input text.

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