510(k) K192707 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Optiflux F180NR Dialyzer
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 21, 2020 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192707
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.