SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
FDA 510(k) clearance K031738 · decided 2004-05-27
Clearance details
- K-number
- K031738
- Device name
- SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
- Applicant
- Smiths Medical MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-04
- Decision date
- 2004-05-27
- Days to decision
- 358 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous recall (Z-1590-2008) | Smiths Medical MD, Inc. | 2008-09-01 |
| Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Del recall (Z-1591-2008) | Smiths Medical MD, Inc. | 2008-09-01 |
| Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smith recall (Z-1622-2008) | Smiths Medical MD, Inc. | 2008-08-15 |