Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052448
    Device Name
    POCKET BREATHALYZER. CONNECTABLES
    Manufacturer
    CONNECTABLES, LLC
    Date Cleared
    2006-02-23

    (169 days)

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

    CONNECTABLES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
    Device Description
    The Connectables® 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® 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.
    Ask a Question

    Page 1 of 1