Biofourmis Singapore Pte., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233418 | Biofourmis Everion+ (G2) | May 9, 2024 |
| K213863 | Everion+ System | February 23, 2023 |
| K183282 | Biovitals Analytics Engine | August 15, 2019 |
| K182344 | RhythmAnalytics | March 7, 2019 |