510(k) K170790 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
SAM CRRT Unit, SAM Cassette CRRT
| Applicant | Spectral Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Dec 13, 2017 |
| Received | Mar 16, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K170790
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.