510(k) K130867 ยท LGZ Warmer, Thermal, Infusion Fluid
ENFLOW IV FLUID WARMER INSULATED STRAP
| Applicant | Vital Signs, Inc., A GE Healthcare Company, Totowa NJ, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Mar 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | None listed |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.