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510(k) Data Aggregation

    K Number
    K014071
    Device Name
    PMX DISPOSABLE BAG MASK RESUSCITATOR
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2002-10-01

    (295 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PMX Disposable Bag Mask Resuscitator are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The child model is intended for patients weighting between 10 and 40 kg and the adult model is intended for patients weighting more than 40 kg approximate weight.

    Device Description

    manual resuscitators incorporating a bag and valve

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a manual emergency ventilator. It does not contain any information about acceptance criteria or a study demonstrating the device meets those criteria.

    The letter primarily:

    • Confirms the device (PMX Disposable Bag Mask Resuscitator) is substantially equivalent to a predicate device.
    • Outlines general regulatory requirements for the manufacturer.
    • States the intended use of the device.

    Therefore, I cannot extract the requested information based on the input text.

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