510(k) K011096 ยท FRN Pump, Infusion
ABBOTT ACCLAIM ENCORE, MODEL 12237
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 1, 2001 |
| Received | Apr 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2014 | Hospira Inc. Hospira Acclaim Encore Infusion Pump
Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration se Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.