510(k) K083019 ยท FRN Pump, Infusion
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Oct 22, 2008 |
| Received | Oct 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | None listed |
| Apr 30, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | None listed |
| Apr 26, 2013 | Hospira Inc. GemStar Pump - Battery
Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is Terminated |
FRN | None listed |
| Apr 26, 2013 | Hospira Inc. GemStar Pump - Battery
Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is r Terminated |
FRN | None listed |
| Apr 15, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | None listed |
| Apr 15, 2013 | Hospira Inc. The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered Terminated |
FRN | None listed |
| Apr 26, 2012 | Hospira Inc. GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027 Terminated |
FRN | None listed |
| Apr 15, 2011 | Hospira Inc. GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01
A stand-alone PC application for administration of medications s Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.