LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K061922
    Device Name
    BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
    Manufacturer
    SENTECH KOREA CORP.
    Date Cleared
    2006-10-30

    (115 days)

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

    SENTECH KOREA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alco-Scan AL-5000 Breath Alcohol Tester is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    AL-5000 is a Breath-alcohol tester designed to measure alcohol in the human breath. And AL-5000 is a D.O.T. approved device and a blow time of 3 seconds is required to capture an accurate deep lung sample. AL-5000 is operated by gas sensor of semi-conductors type for the detection of blood alcohol concentration ( BAC ) from human breath.
    Ask a Question
    K Number
    K060343
    Device Name
    BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
    Manufacturer
    SENTECH KOREA CORP.
    Date Cleared
    2006-05-11

    (90 days)

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

    SENTECH KOREA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication. The AL-6000 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 AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
    Ask a Question
    K Number
    K053332
    Device Name
    BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
    Manufacturer
    SENTECH KOREA CORP.
    Date Cleared
    2006-01-20

    (50 days)

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

    SENTECH KOREA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1