Adjunctive Pain Measurement Device For Anesthesiology
Anesthesiology · 21 CFR 868.2200
An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patients actual response to painful stimuli and is not intended to independently direct decision-making.
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