510(k) K043590 ยท FRN Pump, Infusion
SE INFUSION SYSTEM WITH MMS
| Applicant | Cardinal Health, Alaris Products, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 25, 2005 |
| Received | Dec 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2006 | Cardinal Health 303 Inc DBA Alaris Products Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.