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510(k) Data Aggregation

    K Number
    K030864
    Device Name
    VADI MANUAL RESUSCITATOR
    Manufacturer
    VEDI CORP.
    Date Cleared
    2004-01-30

    (318 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 VADI Manual Resuscitator is designed for use as an adjunct to artificial respiration and cardiopulmonary resuscitation. The Resuscitator can be used to ventilate the aphonic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Vedi Manual Resuscitator, indicating that it has been found substantially equivalent to a predicate device. It specifies general regulatory requirements and the device's indications for use.

    It does not include:

    1. A table of specific acceptance criteria and reported device performance.
    2. Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    3. Information on multi-reader multi-case studies or standalone algorithm performance.
    4. Training set details.
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