QVE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adjunctive Pain Measurement Device For Anesthesiology

Device class

Class II (moderate risk)

Regulation

21 CFR 868.2200

Medical specialty

Anesthesiology

FDA definition

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 patient’s actual response to painful stimuli and is not intended to independently direct decision-making.

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