510(k) K974778 ยท FRN Pump, Infusion
ABBOTT GEMSTAR IV INFUSION PUMP
| Applicant | Abbott Laboratories, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 17, 1998 |
| Received | Dec 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974778
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2003 | Abbott Laboratories Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version Terminated |
FRN | None listed |
| Apr 1, 2003 | Abbott Laboratories Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version Terminated |
FRN | None listed |
| Apr 1, 2003 | Abbott Laboratories Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.