510(k) K100705 ยท FRN Pump, Infusion
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
| Applicant | Zyno Medical, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jul 8, 2010 |
| Received | Mar 12, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2025 | Zyno Medical LLC Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | None listed |
| Jun 6, 2025 | Zyno Medical LLC Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | None listed |
| Jun 6, 2025 | Zyno Medical LLC Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | None listed |
| Jun 6, 2025 | Zyno Medical LLC Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Open, Classified |
FRN | None listed |
| Nov 22, 2024 | Zyno Medical LLC Brand Name: Z-800 Infusion System
Product Name: Z-800WF
Model/Catalog Number: Z-800WF.
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood prod Open, Classified |
FRN | None listed |
| Nov 21, 2024 | Zyno Medical LLC Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF.
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to Open, Classified |
FRN | None listed |
| Oct 9, 2024 | Zyno Medical LLC Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;
Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Open, Classified |
FRN | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.