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510(k) Data Aggregation

    K Number
    K062545
    Device Name
    RMI LCD ALCOHOL DETECTOR
    Date Cleared
    2007-04-09

    (222 days)

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

    RESOURCE MANAGEMENT INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to measure alcohol in human breath. Measurements obtained by this device are used in the detection of alcohol intoxication.
    Device Description
    The RMI® LCD Alcohol Tester is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1. The RMI® LCD Alcohol Tester is an alcohol screening device and uses a blowing time of 3 seconds to capture an accurate deep lung sample. The RMI® LCD Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement. The device employs a 3 digit LCD display which shows breath alcohol readings from 0.00 to 0.20 BAC (Breath Alcohol Concentration). Readings above 0.20 will display an LCD reading of "HI." The new device is a MODIFICATION of our old device, the Connectables® Alcohol Tester (K052448). We use the same sensor, but instead of three colored LEDs as indicators, the new device has a three digit LCD display of the measured BAC (breath alcohol concentration). Instead of analog comparators, we now employ an 8 bit microprocessor for control and measurement.
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