510(k) K193670 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
| Applicant | Quanta Dialysis Technologies, Ltd., Alcester, GB |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Dec 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193670
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.