WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final rule classifying the monitor for opioid induced impairment of oxygenation as a class II medical device with special controls, establishing regulatory requirements intended to provide reasonable assurance of the device's safety and effectiveness while allowing future manufacturers to seek market clearance through the 510(k) process.

The rule took effect . . .

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