1 device · 1 company · 2023
Product code QVE: Adjunctive Pain Measurement Device For Anesthesiology
1 device under product code QVE, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Adjunctive Pain Measurement Device For Anesthesiology. 21 CFR 868.2200, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| PMD-200DEN210022 · De Novo | Medasense Biometrics Ltd. | Anesthesiology | database entry |
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