510(k) K131908 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 11, 2013 |
| Received | Jun 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131908
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.