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AlcoHawk Pro
Breathalyzer & AlcoHawk Precision Breathalyzer
The U.S. Food and Drug Administration's
Center for Devices and Radiological Health (CDRH)
is responsible for regulating firms who
manufacture, repackage, relabel, and/or import
medical devices sold in the United States.
Before granting approval to manufacturers to
sell their new devices, FDA science experts
review the manufacturers data from
investigational studies to see if:
- the product does what it claims to do
effectively, and
- does not present any unreasonable risks
to the user
After reviewing the Alcohawk Series, the FDA has
granted marketing clearance for The Alcohawk
Series Digital Breathalyzers for use in
measuring alcohol intoxication. The Alcohawk and
Alcohawk Pro Breathalyzers have been tested for
accuracy, reliability, and usability, and they
are approved for use by consumers in the U.S.
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