510(k) K211370 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo Hemodialysis System
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jul 29, 2022 |
| Received | May 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2023 | Outset Medical, Inc. Outset Tablo
Model Numbers (REF):
PN-0006000
PN-0007001
Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis Open, Classified |
FIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.