K124035 is an FDA 510(k) clearance for the 2008K@HOME HEMODIALYSIS MACHINE. This device is classified as a Hemodialysis System For Home Use (Class II - Special Controls, product code ONW).
Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on July 3, 2013, 187 days after receiving the submission on December 28, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860. To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients..
| 510(k) Number | K124035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2012 |
| Decision Date | July 03, 2013 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ONW — Hemodialysis System For Home Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |
| Definition | To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients. |