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510(k) Data Aggregation

    K Number
    K072214
    Device Name
    PORTABLE VENTILATOR, MODEL EPV-100
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-03-06

    (210 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PORTABLE VENTILATOR, MODEL EPV-100

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to formulate an answer about acceptance criteria, study details, and device performance. The document is a 510(k) clearance letter from the FDA for a portable ventilator, and it primarily discusses regulatory approval, not device performance or study specifics.

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