The following data is part of a premarket notification filed by Ideal Life Inc. with the FDA for Ideal Life Gluco-manager Blood Glucose Monitoring System.
| Device ID | K132180 |
| 510k Number | K132180 |
| Device Name: | IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | IDEAL LIFE INC. 2995 STEVEN MARTIN DRIVE Fairfax, VA 22031 |
| Contact | Daine Horwitz |
| Correspondent | Daine Horwitz IDEAL LIFE INC. 2995 STEVEN MARTIN DRIVE Fairfax, VA 22031 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2014-06-25 |
| Summary: | summary |