The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Pack H Hemodialysis Urea Kinetic Modeling Software Program.
| Device ID | K955423 |
| 510k Number | K955423 |
| Device Name: | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Tom Folden |
| Correspondent | Tom Folden FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-06-13 |