510(k) K200741 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, Mar 31, 2020 |
| Received | Mar 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.