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510(k) Data Aggregation

    K Number
    K981307
    Device Name
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
    Manufacturer
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.
    Date Cleared
    1998-07-06

    (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

    The International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.

    Device Description

    International Respiratory Systems, Inc.'s Manual Resuscitator

    AI/ML Overview

    I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Manual Pulmonary Resuscitator. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain information about:

    • Acceptance criteria and reported device performance in a table format.
    • Details of a study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
    • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request based on the provided text.

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