510(k) K060876 ยท LZG Pump, Infusion, Insulin
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
| Applicant | Disetronic Medical Systems AG, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 15, 2006 |
| Received | Mar 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2009 | Disetronic Medical Systems, Inc. Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.