510(k) K201809 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
| Applicant | Baxter Healthcare Corportation, Round Lake IL, US |
| Decision | Substantially Equivalent, Mar 10, 2021 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201809
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.