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510(k) Data Aggregation

    K Number
    K052804
    Device Name
    BREATHKEY MODEL G10/BREATHKEY MODEL G30X
    Manufacturer
    OMEGAPOINT SYSTEMS, LLC
    Date Cleared
    2005-12-09

    (66 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMEGAPOINT SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
    Device Description
    The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle. The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
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