K955423 is an FDA 510(k) clearance for the PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM, a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on June 13, 1996, 198 days after receiving the submission on November 28, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K955423 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1995 |
| Decision Date | June 13, 1996 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |