510(k) K233798 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Moda-flx Hemodialysis System and Cartridge
| Applicant | Diality, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 2, 2024 |
| Received | Nov 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233798
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.