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510(k) Data Aggregation

    K Number
    K982722
    Device Name
    AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
    Manufacturer
    AMBU, INC.
    Date Cleared
    1999-04-12

    (250 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ambu MediBag Adult Resuscitator is intended for pulmonary resuscitation of adult patients with a body weight of more than 66 lbs (30 kg) and for administration of inhaled B-adrenergic agonist for emergency patients in acute asthma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Ambu MediBag Adult and Infant/Child Resuscitator. It primarily focuses on regulatory approval and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving those criteria.

    Therefore, I cannot provide the requested information from this document. The document confirms the device is substantially equivalent to a predicate device and meets the requirements of ASTM F920-93 (with one exception for temperature range) but does not elaborate on the specific studies or data mentioned in your questions.

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