510(k) K163530 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PrisMax Control Unit
| Applicant | Baxter Healthcare Corp, Brooklyn Park Mn MN, US |
| Decision | Substantially Equivalent, May 3, 2017 |
| Received | Dec 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163530
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.