BEUDAMED
    2 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

    FDA Enforcement
    Class III ·Terminated·Acon Laboratories, Inc.·August 5, 2015

    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

    FDA Enforcement
    Class III ·Terminated·BC Group International Inc·December 30, 2015