The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Deltec Cozmo Insulin Infusion Pump With Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817.
| Device ID | K062323 |
| 510k Number | K062323 |
| Device Name: | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 |
| Classification | Pump, Infusion, Insulin |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-11-01 |
| Summary: | summary |