510(k) K883111 ยท FKP System, Dialysate Delivery, Single Patient
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Feb 8, 1989 |
| Received | Jul 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2010 | Baxter Healthcare Renal Div Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Terminated |
FKP | None listed |
| Mar 20, 2003 | Baxter Healthcare Corp. Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.