The following data is part of a premarket notification filed by Sophysa, Sa with the FDA for Pressio 2 Icp Monitoring System.
| Device ID | K162108 |
| 510k Number | K162108 |
| Device Name: | Pressio 2 ICP Monitoring System |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | SOPHYSA, SA 5, Rue Guy Moquet Orsay, Cedex, FR 91400 |
| Contact | Jean-christophe Audras |
| Correspondent | Etienne Duhot SOPHYSA, SA 5, Rue Guy Moquet Orsay, Cedex, FR 91400 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2017-04-17 |
| Summary: | summary |