510(k) K031738 ยท LZG Pump, Infusion, Insulin
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, May 27, 2004 |
| Received | Jun 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1700.
A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes.
Reorder Numbers:
21-1701-02/32/33/36/44/49/51/54/6 Terminated |
LZG | None listed |
| Sep 1, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1800.
This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and Terminated |
LZG | None listed |
| Aug 15, 2008 | Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous I Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.