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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    PN MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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)
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