Livongo Health
FDA Regulatory Profile
Livongo Health appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1587-2016, Class II) was initiated on February 18, 2016. Its most recent 510(k) clearance was granted on June 4, 2020.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1587-2016 | Class II | The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) sy | February 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200277 | Livongo Blood Glucose Monitoring System (BG1000) | June 4, 2020 |