510(k) K210661 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
| Applicant | Quanta Dialysis Technologies, Ltd., Alcester, GB |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Mar 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210661
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.