www.fdanews.com/articles/177566-soberlink-scoops-up-510k-premarket-clearance-for-breathalyzer
Soberlink Scoops Up 510(k) Premarket Clearance for Breathalyzer
July 15, 2016
Huntington Beach, Calif.-based Soberlink has received 510(k) premarket clearance for its Soberlink Breathalyzer, which can remotely measure alcohol on human breath.
The device was granted clearance for medical use by healthcare providers.
The breathalyzer, alongside the company’s Sober Sky Web Portal accountability tool, is intended to detect and manage alcohol consumption in people suffering from alcohol use disorders. — Anisa Jibrell