The following data is part of a premarket notification filed by Cybernius Medical Ltd. with the FDA for Cyberren.
| Device ID | K970989 |
| 510k Number | K970989 |
| Device Name: | CYBERREN |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | CYBERNIUS MEDICAL LTD. SUITE 200, GRANDIN PARK PLAZA 22 SIR WINSTON CHURCHILL AVE. St. Albert, Alberta, CA T8n 1b4 |
| Contact | Ulrich Simonsmeier |
| Correspondent | Ulrich Simonsmeier CYBERNIUS MEDICAL LTD. SUITE 200, GRANDIN PARK PLAZA 22 SIR WINSTON CHURCHILL AVE. St. Albert, Alberta, CA T8n 1b4 |
| Product Code | KPF |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-18 |
| Decision Date | 1997-07-24 |