Panels › Gastroenterology, Urology › Product code ONW · Class 2
Hemodialysis System For Home Use
Regulation 876.5860
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ONW
| Company | 510(k)s | Recalls |
|---|---|---|
| Fresenius Medical Care Holdings, Inc. | 0 | 4 |
| Fresenius Medical Care North America | 2 | 0 |
| Fresenius Medical Care North America, Design Cente | 1 | 0 |
| Quanta Dialysis Technologies, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2024 | K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) Quanta Dialysis Technologies, Ltd., GB | ONW |
| Jul 3, 2013 | K124035 | 2008K@HOME HEMODIALYSIS MACHINE Fresenius Medical Care North America | ONW |
| Jan 17, 2013 | K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) Fresenius Medical Care North America, Design Cente | ONW |
| Feb 3, 2011 | K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR Fresenius Medical Care North America | ONW |
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