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510(k) Data Aggregation

    K Number
    K982215
    Device Name
    MANUAL RESUSCITATOR WITH ACE
    Manufacturer
    MEDICAL MARKETING CONCEPTS
    Date Cleared
    1998-09-18

    (87 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

    Manual ventilation and assist in verification of endotracheal tube placement

    Device Description

    Manual Resuscitator with ACE

    AI/ML Overview

    I am sorry, but the provided text from the FDA document (K982215) is a letter regarding the substantial equivalence determination for a "Manual Resuscitator with ACE" device. It does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or any performance metrics for the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document is a regulatory approval letter, not a scientific study report.

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