LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080063
    Device Name
    MASS CASUALTY VENTILATOR, MODEL MCV100
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Date Cleared
    2008-08-15

    (218 days)

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

    MASS CASUALTY VENTILATOR, MODEL MCV100

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

    The MCV100 and MCV100-B are intended to be used as an electrically controlled, electrical / gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the MCV100 Ventilator and MCV100-B Ventilator. This type of document does not contain the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was approved based on its similarity to existing, approved devices, not necessarily on a detailed study proving its performance against specific acceptance criteria as you've outlined.

    Therefore, I cannot extract the requested information from this document. It does not describe a study involving performance metrics, expert adjudication, or AI components.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1