DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
FDA 510(k) clearance K062323 · decided 2006-11-01
Clearance details
- K-number
- K062323
- Device name
- DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
- Applicant
- Smiths Medical MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-09
- Decision date
- 2006-11-01
- Days to decision
- 84 days
- Clearance type
- Special
- 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 1800. Deltec Cozmo Insulin Pumps are ambulatory electrome recall (Z-0988-2009) | Smiths Medical MD, Inc. | 2009-04-16 |
| Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps recall (Z-0989-2009) | Smiths Medical MD, Inc. | 2009-04-16 |
| 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 |
| Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths recall (Z-1623-2008) | Smiths Medical MD, Inc. | 2008-08-15 |