The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Aviator Insulin Delivery And Blood Glucose Monitoring System.
| Device ID | K083225 |
| 510k Number | K083225 |
| Device Name: | FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-02-20 |
| Summary: | summary |