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    K Number
    K042682
    Device Name
    AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-11-15

    (47 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR

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

    The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a medical device called the "Ambu® SPUR® II Adult Single Patient Use Resuscitator." This type of document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. This substantial equivalence is assessed based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria and ground truth as would be reported for an AI/ML diagnostic device.

    Therefore, I cannot provide the requested table and information based on the provided text.

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