Panels › General Hospital › Product code OPP · Class 2
Pump, Infusion, Insulin Bolus
Regulation 880.5725
1510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OPP
| Company | 510(k)s | Recalls |
|---|---|---|
| Calibra Medical, Inc. | 3 | 0 |
| Cequr SA | 3 | 0 |
| Lifescan Europe, A Division of Cilag GmbH | 1 | 0 |
| Zyno Medical LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2013 | Zyno Medical LLC Z-800 Volumetric Infusion System.
For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Terminated |
OPP | K071545 K100705 |
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