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510(k) Data Aggregation

    K Number
    K070120
    Device Name
    AUTOVENT MODEL 4000
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2007-05-03

    (111 days)

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

    AUTOVENT MODEL 4000

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

    The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

    Device Description

    Autovent 4000

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "Autovent 4000." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and regulatory compliance.

    Unfortunately, the document does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report.

    Therefore, I cannot extract the requested information from the provided text.

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