510(k) K223248 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo® Hemodialysis System
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 21, 2023 |
| Received | Oct 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223248
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.