510(k) K042887 ยท LZG Pump, Infusion, Insulin
ACCU-CHEK SPIRIT
| Applicant | Disetronic Medical Systems AG, Burgdorf, CH |
| Decision | Substantially Equivalent, Mar 18, 2005 |
| Received | Oct 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit insulin infusion pump. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.