510(k) K190793 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo Hemodialysis System, Tablo Cartridge
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Dec 12, 2019 |
| Received | Mar 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190793
| 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 |
| Jan 20, 2022 | Outset Medical, Inc. Outset Tablo Console
Model Number: PN-0003000
Model Number: PN-0006000 Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.