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510(k) Data Aggregation

    K Number
    K012368
    Device Name
    AEROPEP
    Manufacturer
    TRUDELL MEDICAL INTL.
    Date Cleared
    2002-02-12

    (201 days)

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

    The "AERO PEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device can be used as a PEP device alone or in conjunction with the r roosal of aerosolized medication from a pressurized metered dose inhaler (pMDI) as prescribed by a physician or health care provider .

    Device Description

    AeroPEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a clearance letter from the FDA regarding a 510(k) premarket notification for a medical device called AeroPEP™. It establishes substantial equivalence to a predicate device and provides regulatory information, but it does not include the specifics of performance testing or clinical studies.

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