510(k) K955423 ยท FKP System, Dialysate Delivery, Single Patient
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
| Applicant | Fresenius USA, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Jun 13, 1996 |
| Received | Nov 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955423
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.