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What
is DOT/NHTSA Approval?
The US DOT (Department of Transportation) regulates
the rules and guidelines that oversee all vehicles
that travel throughout the country. The NHTSA (National
Highway Traffic Safety Administration) ensures that
roads and highways are safe to drive on. Together,
these two agencies test the accuracy and reliability
of many related devices, including breathalyzers (in
the prevention of alcohol-related vehicle accidents).
Our main products have all been approved as accurate
and reliable by the DOT and NHTSA.
What
is FDA 510(k) Certification?
The
US FDA (Food & Drug Administration) oversees all
food, drug and related products that are to be sold
in the US. This includes "medical devices,"
the category into which breathalyzers, or breath alcohol
testers, are placed. The FDA issues 510(k) certification
to devices that meet the strict quality control standards
for device presentation, function, use and instructions,
as required by the FDA. The AlcoMate, AlcoMate Pro,
AlcoMate Prestige (Model AL6000), the AlcoScan AL5000
and AlcoScan AL2500 have all received FDA 510(k) certification.
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