Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2200](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2200) → QVE — Adjunctive Pain Measurement Device For Anesthesiology

# QVE · Adjunctive Pain Measurement Device For Anesthesiology

_Anesthesiology · 21 CFR 868.2200 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/QVE

## Overview

- **Product Code:** QVE
- **Device Name:** Adjunctive Pain Measurement Device For Anesthesiology
- **Regulation:** [21 CFR 868.2200](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2200)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN210022](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/QVE/DEN210022.md) | PMD-200 | Medasense Biometrics , Ltd. | Feb 17, 2023 | DENG |

## Top Applicants

- Medasense Biometrics , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/QVE](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/QVE)

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