510(k) K124035 ยท ONW Hemodialysis System For Home Use
2008K@HOME HEMODIALYSIS MACHINE
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 3, 2013 |
| Received | Dec 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K124035
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.