QVE

Adjunctive Pain Measurement Device For Anesthesiology

Product code: QVE
Device name: Adjunctive Pain Measurement Device For Anesthesiology
Device class: Class 2
21 CFR: 21 CFR 868.2200
Medical specialty: Anesthesiology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification 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 patients actual response to painful stimuli and is not intended to independently direct decision-making.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QVE

Classification and pathway per current FDA publications. Data from openFDA (CC0).