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510(k) Data Aggregation

    K Number
    K972042
    Device Name
    PARI PEP THERAPY SYSTEM
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1997-08-05

    (64 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K090829,K991788
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.

    Device Description

    The PARI PEP Device is an Expiratory Resistance Exerciser. The PARI PEP was designed to work with the PARI Nebulizers.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with a test set, training set, or expert involvement to establish ground truth. The document is an FDA letter regarding the substantial equivalence of the PARI PEP® Positive Expiratory Pressure Therapy System, which primarily discusses regulatory classification and marketing authorization. It does not include a technical or clinical study summary.

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