510(k) K071545 ยท FRN Pump, Infusion
Z-800 VOLUMETRIC INFUSION PUMP
| Applicant | Zyno Medical, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 31, 2007 |
| Received | Jun 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071545
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.