510(k) K970591 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
BLOOD MONITOR PUMP
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | Feb 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3051, 5M3051R Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.