510(k) K150880 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo Console with Wireless Capability
| Applicant | Outset Medical, San Jose CA, US |
| Decision | Substantially Equivalent, May 1, 2015 |
| Received | Apr 1, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150880
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.