510(k) K061515 ยท KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
RENALSOFT
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Jun 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | None listed |
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085. Terminated |
KPF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.