510(k) K232171 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Purema® H Hemoconcentrator (EtO Sterilized)
| Applicant | Tecnoideal America, Derwood MD, US |
| Decision | Substantially Equivalent, Feb 7, 2024 |
| Received | Jul 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232171
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.