K930181 is an FDA 510(k) clearance for the BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE, 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 November 29, 1995, 1049 days after receiving the submission on January 14, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K930181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 1993 |
| Decision Date | November 29, 1995 |
| Days to Decision | 1049 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 |