510(k) K124018 ยท FKX System, Peritoneal, Automatic Delivery
AMIA AUTOMATED PD SYSTEM
| Applicant | Deka Research & Development Corp., Manchester NH, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Dec 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K124018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2015 | Baxter Healthcare Corp. Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis. Terminated |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.