LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K063443
    Device Name
    DRAEGER ALCOTEST 6510
    Manufacturer
    DRAGER SAFETY
    Date Cleared
    2008-03-11

    (483 days)

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

    DRAGER SAFETY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dräger Alcotest 6510 is an apparatus for indicating the presence of alcohol in the breath. The Dräger Alcotest 6510 is a device intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The Drager Alcotest 6510 is designed to measure deep lung air to determine the level of alcohol in the blood. The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
    Ask a Question

    Page 1 of 1