QVE — Adjunctive Pain Measurement Device For Anesthesiology Class II
FDA product code QVE covers "Adjunctive Pain Measurement Device For Anesthesiology", a Class II medical device regulated under 21 CFR 868.2200. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVE
- Device Class
- Class II
- Regulation Number
- 868.2200
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210022 | medasense biometrics | PMD-200 | February 17, 2023 |