The following data is part of a premarket notification filed by Cyberex Corp. with the FDA for Repgreen Ultrafiltration Monitor.
| Device ID | K790824 |
| 510k Number | K790824 |
| Device Name: | REPGREEN ULTRAFILTRATION MONITOR |
| Classification | System, Dialysate Delivery, Single Pass |
| Applicant | CYBEREX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIL |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-01 |
| Decision Date | 1979-06-27 |