510(k) K112314 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
| Applicant | Nephros, Inc., River Edge NJ, US |
| Decision | Substantially Equivalent, Apr 27, 2012 |
| Received | Aug 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112314
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.