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510(k) Data Aggregation

    K Number
    K971084
    Device Name
    MODEL 02 OXYGEN ANALYZER
    Manufacturer
    Date Cleared
    1998-07-21

    (483 days)

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

    OXIGRAF, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model O2 is intended to provide continuous, direct patient monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia and breathing machines), respiratory therapy (e.g., breathing circuits, respirators, ventilators and pediatric incubators), and oxygen therapy (e.g., oxygen concentrators, tents, masks and nasal cannulas). The Model O2 is designed to be used by trained health care professionals under the supervision of a physician in a hospital, clinic, or emergency medicine setting.
    Device Description
    The Model 02 Fast Oxygen Analyzer consists of laser diode oxygen sensor, sampling pump, pressure sensor, flow and gas temperature controllers, displays, keypad, and alarm packaged in an instrument case. The oxygen concentration displayed is corrected with respect to any changes in barometric or ambient temperature. Calibration may be performed using the keypad and display prompts. Audible and visual alarms are available for low and high oxygen concentration and for low flow and high pressure. The unit is powered by an external 12 volt, 2 amp universal input power supply. Non-sterile inlet filters and airway adapter sets labeled "single patient use" remove water from the sampled gas.
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