510(k) K043000 ยท LZG Pump, Infusion, Insulin
MODIFICATION TO D-TRONPLUS
| Applicant | Disetronic Medical Systems AG, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 1, 2004 |
| Received | Nov 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2006 | Disetronic Medical Systems, Inc. Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. Terminated |
LZG | None listed |
| Aug 6, 2005 | Roche Diagnostics Corp. Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters. Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.