Bedfont Scientific Ltd. has made a 510(k) submission for US FDA clearance of their ToxCO® monitor used by emergency services to mass screen for carbon monoxide (CO) poisoning.
The medical device manufacturer has made an FDA 510(k) submission for clearance to sell breath analyser the ToxCO.
Established in 1976, the second-generation family company already has one device on the market in America, their Micro+™ Smokerlyzer® CO monitor to help people quit smoking. Using a similar technology, the ToxCO can instantly diagnose CO poisoning by analysing a breath sample from the patient to determine the level of CO in their blood.
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