DEN210022 is an FDA 510(k) submission for the PMD-200. This device is classified as a Adjunctive Pain Measurement Device For Anesthesiology (Class II - Special Controls, product code QVE).
Submitted by Medasense Biometrics , Ltd. (Ramat Gan, IL). The FDA issued a Not Cleared (DENG) decision on February 17, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2200. 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..
| 510(k) Number | DEN210022 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 04, 2021 |
| Decision Date | February 17, 2023 |
| Days to Decision | 623 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | QVE - Adjunctive Pain Measurement Device For Anesthesiology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2200 |
| 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. |