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510(k) Data Aggregation

    K Number
    K042843
    Device Name
    AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-11-12

    (29 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K094003,K152931,K181583
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).

    The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Ambu, Inc. regarding their Ambu® SPUR® II resuscitators. This document primarily focuses on regulatory approval and indications for use.

    It does not contain any information about:

    • Acceptance criteria for a device's performance regarding a specific study.
    • Results from any studies proving criteria are met.
    • Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

    Therefore, I cannot fulfill your request for this specific information based on the text provided.

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