K101715 is an FDA 510(k) clearance for the FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Fresenius Medical Care North America, Design Cente (Waltham, US). The FDA issued a Cleared decision on December 21, 2010, 186 days after receiving the submission on June 18, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K101715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2010 |
| Decision Date | December 21, 2010 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |