510(k) K894838 ยท FKP System, Dialysate Delivery, Single Patient
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 7, 1989 |
| Received | Jul 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2004 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FII | None listed |
| Mar 20, 2003 | Baxter Healthcare Corp. Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, 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.