The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Pressio Icp Monitoring System.
| Device ID | K062584 |
| 510k Number | K062584 |
| Device Name: | PRESSIO ICP MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | SOPHYSA SA 2884 DANAPOPLAR Dana Point, CA 92629 |
| Contact | Esther Saltz |
| Correspondent | Esther Saltz SOPHYSA SA 2884 DANAPOPLAR Dana Point, CA 92629 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2007-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124130676 | K062584 | 000 |
| 03760124131482 | K062584 | 000 |
| 03760124130782 | K062584 | 000 |
| 03760124130768 | K062584 | 000 |
| 03760124131512 | K062584 | 000 |
| 03760124131499 | K062584 | 000 |
| 03760124131635 | K062584 | 000 |
| 03760124130751 | K062584 | 000 |
| 03760124130744 | K062584 | 000 |