510(k) K042800 ยท MEA Pump, Infusion, Pca
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Oct 18, 2004 |
| Received | Oct 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | Hospira Inc. The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits. Terminated |
MEA | None listed |
| Mar 8, 2013 | Hospira Inc. LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709
Allows for clinician administration or self-administration of analgesic medications. Terminated |
MEA | None listed |
| Mar 8, 2013 | Hospira Inc. LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or ho Terminated |
MEA | None listed |
| Mar 8, 2013 | Hospira Inc. LifeCare PCA 3, PCA Serial List Number 12384
Allows for clinician administration or self-administration of analgesic medications. Terminated |
MEA | None listed |
| Oct 6, 2009 | Hospira Inc LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospi Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.