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510(k) Data Aggregation

    K Number
    K972824
    Device Name
    THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
    Manufacturer
    PN MEDICAL
    Date Cleared
    1998-04-03

    (247 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K944412
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.

    Device Description

    The Breather (Inspiratory/Expiratory Muscle Trainer)

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance of "The Breather (Inspiratory/Expiratory Muscle Trainer)".

    The document is a US FDA 510(k) clearance letter for the device, indicating that it has been found substantially equivalent to a predicate device. It specifies the regulatory class, product code, and a new intended use for the device (to assist in breathing coordination during nebulization treatments). However, it does not include any performance data, study results, or specific acceptance criteria for the device itself.

    Therefore, I cannot provide the requested table and study details based on the given text.

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