510(k) K121613 ยท FRN Pump, Infusion
AGILIA INFUSION SYSTEM
| Applicant | Fresenius Kabi AG, Lake Zurich IL, US |
| Decision | Substantially Equivalent, May 1, 2013 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2019 | Fenwal Inc VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a
Product Usage:
The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare f Terminated |
FRN | None listed |
| Dec 2, 2017 | Fresenius Vial Sa Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthca Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.