Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K080848
    Device Name
    ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
    Manufacturer
    Q3 INNOVATIONS, LLC
    Date Cleared
    2008-07-25

    (121 days)

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

    Q3 INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The AlcoHAWK® PT500 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 AlcoHAWK® PT500 has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoHAWK® PT500 sensor uses a fuel cell type of detector similar to one found on professional units. It is handheld and uses two AA alkaline batteries as a power source. The mouthpiece is replaceable Plexiglas plastic.
    Ask a Question
    K Number
    K043188
    Device Name
    ALCOHAWK PRECISION
    Manufacturer
    Q3 INNOVATIONS, LLC
    Date Cleared
    2005-02-09

    (84 days)

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

    Q3 INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The Alcohawk Precision™ 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 Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide 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.
    Ask a Question

    Page 1 of 1