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510(k) Data Aggregation

    K Number
    K012842
    Device Name
    V*CARE MANUAL RESUSCITATOR
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2001-09-18

    (26 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K053466
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to provide artificial ventilation for the emergency treatment of reversible apnea, commonly associated with cardiopulmonary arrest.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the V*Care Manual Resuscitator with Built-in Pressure Monitor. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The text provided is a regulatory clearance document, not a clinical study report or a technical performance evaluation. Therefore, I cannot extract the requested information from this document.

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