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510(k) Data Aggregation

    K Number
    K963415
    Device Name
    VENTREX OXYGEN SENSOR
    Manufacturer
    Date Cleared
    1996-11-25

    (87 days)

    Product Code
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTREX, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Each device has similar intended uses. The VENTREX line of oxygen sensors and predicate devices have similar clinical applications. Each is used to determine the amount (expressed as % O2) of oxygen present in an atmosphere.
    Device Description
    The VENTREX line of oxygen sensors are medical devices which produce an electrical current which is directly proportional to the amount of oxygen contained in a gas mixture. Like any oxygen sensor, the VENTREX oxygen sensor electrical out-put must be interpreted by an electronic monitoring instrument. As is the case with all oxygen sensors, the VENTREX sensors will be used in the hospital, in physician offices, out-patient care centers, extended care facilities, homes, emergency medical services and patient transport.
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