The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Copilot Health Management System.
| Device ID | K062770 |
| 510k Number | K062770 |
| Device Name: | COPILOT HEALTH MANAGEMENT SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Mary Rose |
| Correspondent | Mary Rose ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2006-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30357599000173 | K062770 | 000 |