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Medical Devices / Submissions and Approvals

Bedfont’s Carbon Monoxide Monitor Nets FDA Clearance

April 15, 2019

The FDA granted 510(k) clearance to Bedfont’s ToxCO breath analysis monitor, a device used to measure the level of carbon monoxide (CO) in a patient’s blood.

The device gauges exhaled CO by the patient to instantly measure the level of CO in the blood. Because of the prompt results, it is intended for use in triaging cases of CO poisoning.

Healthcare professionals can choose between a mouth piece or a face mask for injured or unconscious patients to obtain samples.

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