The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Smiths Medical Insulin Infusion Pump With Cozmonitor Glucose Meter.
| Device ID | K031738 |
| 510k Number | K031738 |
| Device Name: | SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER |
| Classification | Pump, Infusion, Insulin |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | Russ Davies |
| Correspondent | Russ Davies SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2004-05-27 |
| Summary: | summary |