510(k) K193005 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DIMI RRT System
| Applicant | Dialco Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Oct 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193005
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.