The following data is part of a premarket notification filed by Livongo Health, Inc. with the FDA for Livongo Blood Glucose Monitoring System (bg1000).
| Device ID | K200277 |
| 510k Number | K200277 |
| Device Name: | Livongo Blood Glucose Monitoring System (BG1000) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View, CA 94041 |
| Contact | Jacob Gendler |
| Correspondent | Jacob Gendler Livongo Health, Inc. 150 W. Evelyn Ave, Suite 150 Mountain View, CA 94041 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-06-04 |