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510(k) Data Aggregation

    K Number
    K110614
    Device Name
    PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
    Manufacturer
    SEJU ENGINEERING CO., LTD.
    Date Cleared
    2011-11-21

    (263 days)

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

    SEJU ENGINEERING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
    Device Description
    The PAD is a self-contained unit with 3 digit LCD display, and power button. The 3 digit LCD display window displays the alcohol concentration in increment of 0.01%. The display is also capable of displaying L-b, S-E, t-F, L-t, n-C, HI and these states low battery, sensor error, test fail, low temperature, need calibration , high concentration, respectively. The unit is powered by two AAA batteries.
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