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510(k) Data Aggregation

    K Number
    K012271
    Device Name
    ACUTEVENTILATOR
    Manufacturer
    IMPOEX INTERNATIONAL, LTD.
    Date Cleared
    2002-10-04

    (442 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 Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.

    Device Description

    a pumping apparatus of the bellows type, which is adapted for artificial respiration

    AI/ML Overview

    The provided text is a 510(k) summary letter from the FDA regarding a device named "Acuteventilator," which is a manual emergency ventilator. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/Software as a Medical Device (SaMD) submission.

    This document is primarily concerned with the FDA's decision of substantial equivalence of the Acuteventilator to a legally marketed predicate device, falling under the regulatory framework for medical devices (specifically, Class II). It confirms that the device can be marketed in the US.

    Therefore, I cannot provide the requested information from the given input. The requested details (acceptance criteria tables, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) are standard for the evaluation of AI/SaMD, but are not applicable to the type of device and regulatory communication presented here.

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