510(k) K032233 ยท MEA Pump, Infusion, Pca
MEDLEY PCA MODULE, MODEL 8120
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Jul 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2017 | CareFusion 303, Inc. Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion.
The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA Terminated |
MEA | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015;
Alaris Pump Module, Model 8100;
Alaris Patient-Controlled Analges Terminated |
FRN | None listed |
| May 1, 2009 | Cardinal Health 303 dba Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.