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The Alcohawk Series Breathalyzers are FDA 510(k) Certified
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 manufacturer’s 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.
Important Notes:
- previous versions of this product, including products sold without the Alcohawk name, are not FDA certified
- breath alcohol testers that have not been evaluated by the FDA may be dangerous and/or unreliable for consumer use
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.
Click here to go back to Alcohawk Product Page.
Click here to go back to Alcohawk Pro Product Page.
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