Voluntis Sa.
Medical device manufacturer in Paris, FR.
6510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250022 | HeroTracker SenseCAF · Traditional | 06/30/2025SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | 12/12/2023SE |
| K202596 | Insulia Diabetes Management CompanionNDC · Special | 06/04/2021SE |
| K172177 | Insulia Diabetes Management CompanionNDC · Traditional | 11/07/2017SE |
| K170669 | Insulia Diabetes Management CompanionNDC · Traditional | 06/19/2017SE |
| K161433 | Insulia Diabetes Management CompanionNDC · Traditional | 11/09/2016SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0478-2019 Class II | Insulia Diabetes Management CompanionThe firm identified an issue with the basal calculator identified on the Android version of the Insulia… | 10/08/2018Terminated |