510(k) K973044 ยท LZG Pump, Infusion, Insulin
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
| Applicant | Disetronic Medical Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Sep 15, 1997 |
| Received | Aug 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Roche Diagnostics Corp. Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartidges per b Terminated |
LZG | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needle Terminated |
LZG | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured by Dise Terminated |
LZG | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; manufactured for Dis Terminated |
LZG | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured for Dis Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.