510(k) K043299 ยท MEA Pump, Infusion, Pca
MEDLEY PCA MODULE, MODEL 8120
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 10, 2004 |
| Received | Nov 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2020 | CareFusion 303, Inc. BD Alaris System; Alaris Syringe Module Model 8110;
BD Alaris System; Alaris PCA Module Model 8120;
BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 Open, Classified |
FRN | None listed |
| Jun 10, 2008 | Cardinal Health 303 Inc DBA Alaris Products Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Uni Terminated |
FRN | None listed |
| Jun 10, 2008 | Cardinal Health 303 Inc DBA Alaris Products U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005:
(1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe mod Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.