510(k) K210782 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Tablo Cartridge
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Nov 26, 2021 |
| Received | Mar 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210782
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.