510(k) K152938 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DBB-06 Hemodialysis Delivery System
| Applicant | NIKKISO CO., LTD., Shibuya-Ku, JP |
| Decision | Substantially Equivalent, Mar 18, 2016 |
| Received | Oct 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2021 | Nikkiso Ltd - Shizuoka Plant DBB-06 Hemodialysis Delivery System Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.