QVE · Adjunctive Pain Measurement Device For Anesthesiology
Anesthesiology · 21 CFR 868.2200 · Class 2
Overview
| Product Code | QVE |
|---|---|
| Device Name | Adjunctive Pain Measurement Device For Anesthesiology |
| Regulation | 21 CFR 868.2200 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 patients actual response to painful stimuli and is not intended to independently direct decision-making.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210022 | PMD-200 | Medasense Biometrics , Ltd. | Feb 17, 2023 | DENG |
Top Applicants
- Medasense Biometrics , Ltd. — 1 clearance
