510(k) K843963 ยท FKQ System, Dialysate Delivery, Central Multiple Patient
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
| Applicant | Renal Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 7, 1985 |
| Received | Oct 11, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843963
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2021 | Medivators, Inc. Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. Terminated |
FKQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.