510(k) K023471 ยท LZG Pump, Infusion, Insulin
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
| Applicant | Disetronic Medical Systems AG, St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 29, 2002 |
| Received | Oct 15, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2003 | Roche Diagnostics Corp. Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case]. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.