510(k) DEN210022
DEN210022 is an FDA 510(k) premarket notification submitted by Medasense Biometrics , Ltd. for the device "PMD-200". The FDA issued a decision of De Novo Granted on February 17, 2023. The device falls under product code QVE (Adjunctive Pain Measurement Device For Anesthesiology), a Class II device regulated under 21 CFR 868.2200.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 17, 2023
- Date Received
- June 4, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Pain Measurement Device For Anesthesiology
- Device Class
- Class II
- Regulation Number
- 868.2200
- Review Panel
- AN
- Submission Type
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.