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510(k) Data Aggregation

    K Number
    K132903
    Device Name
    DRE VENTURA
    Manufacturer
    Date Cleared
    2014-07-01

    (288 days)

    Product Code
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ventura anesthesia gas delivery machine is designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system.
    Device Description
    The DRE Ventura anesthetic machine is a constant flow anesthesia gas delivery system intended for human use. The intended use for the Ventura anesthesia gas delivery machine is for the application of continuous flow anesthesia in a hospital. office based anesthesia settings, induction room or operating room. The units are intended to provide concentrations and flows of anesthesia gases and vapors into a patient breathing system. The anesthesia machine is designed for use by suitably qualified practitioners only. The basic device is commonly referred to as an anesthesia trolley. The Ventura is fitted with facilities to deliver 3 gases – oxygen, nitrous oxide or air. Up to 4 'E' size cylinders can be fitted along with pipeline supplies for all gases. It has a number of drawers for storage. In order to make the unit fully functional, the Ventura can be fitted with FDA cleared equipment, such as: Anesthetic agent vaporizer, specifically Selectatec compatible designs, Carbon dioxide absorber, Gas scavenging system, Ventilator of the complete standalone type. The Ventura has an anti-hypoxic device is built into the oxygen gas control system to enable a safe supply anesthetic gases under varying flow conditions.
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