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510(k) Data Aggregation

    K Number
    K082086
    Device Name
    KEY RING ALCOHOL BREATHALYZER
    Date Cleared
    2008-12-19

    (149 days)

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

    THE ASHLEY COLLECTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. This devise is intended to measure alcohol in the human breathe. Measurements obtained by this device are use as an aid in the detection of alcohol intoxication.
    Device Description
    Protocol's alcohol breath checker is designed to measure deep lung air to test for the presence of alcohol in the blood. Protocol's breath checker is an alcohol screening device and uses a blow time of at least 3 seconds to capture an accurate deep lung sample. Protocol's alcohol breathe tester contains an oxide semiconductor sensor designed to test for the presence of alcohol. The 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.. The device provides a semi-quantitative measure of a patient's blood alcohol level using colored LEDs as indicators. The indications are: Red & Yellow: BAC 0.08 or more; Yellow: BAC 0.05 to 0.08; Green: BAC < 0.05. The device also includes a flashlight function and a count-up/count-down timer. The timer can be used for parking meter timing or for timing the wait before performing the alcohol test after consuming alcohol, nominally 20 minutes.
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