# Adjunctive Pain Measurement Device For Anesthesiology
> **Product code: QVE** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2200
## Classification
- **FDA Product Code:** QVE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.2200
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QVE)
---
*AI Analytics · CC0 1.0*