510(k) K982640 ยท FRN Pump, Infusion
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
| Applicant | Medex, Inc., Hilliard OH, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Apr 6, 1999 |
| Received | Jul 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2007 | Smiths Medical MD, Inc. Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.