510(k) K210575 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HDF Assist Mudule, HDF Infusion Set and Substitution Filter
| Applicant | Nephros, South Orange NJ, US |
| Decision | Substantially Equivalent, May 13, 2022 |
| Received | Feb 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210575
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.