510(k) K242155 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
| Applicant | NIKKISO CO., LTD., Tokyo, JP |
| Decision | Substantially Equivalent, May 15, 2025 |
| Received | Jul 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242155
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.