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510(k) Data Aggregation

    K Number
    K123470
    Device Name
    PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
    Manufacturer
    PAS SYSTEMS INTERNATIONAL, INC.
    Date Cleared
    2013-04-29

    (167 days)

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

    PAS SYSTEMS INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. The PAS Alcovisor® Mars™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
    Device Description
    The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer are breath alcohol test systems designed to sample a user's deep lung breath in order to test for the presence of alcohol. The sensor is an electrochemical fuel cell which will only respond to alcohol. After the user blows into the device using a disposable mouthpiece, for 3-4 seconds, a small sample of breath is drawn into the fuel cell by an automatic pump and a chemical reaction between the alcohol and fuel cell occurs. This reaction generates an electrical current which is directly related to the amount of alcohol in the sample. The current is then converted to a Blood Alcohol Concentration (BAC) level and displayed for the user. The relationship between alcohol in a person's deep lung breath and in their blood is well established using Henry's law, which gives a ratio of 2100:1. The Satellite™ and Mars™ are handheld devices made from durable plastic with an internal circuit board. The Satellite™ uses an internal rechargeable battery and the Mars™ uses three AAA batteries.
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