Pressio 3 Multi-parameter Neuromonitoring System
Device Facts
| Record ID | K252241 |
|---|---|
| Device Name | Pressio 3 Multi-parameter Neuromonitoring System |
| Applicant | Sophysa |
| Product Code | GWM · Neurology |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1620 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
