The following data is part of a premarket notification filed by Voluntis, S.a. with the FDA for Insulia Diabetes Management Companion.
| Device ID | K202596 |
| 510k Number | K202596 |
| Device Name: | Insulia Diabetes Management Companion |
| Classification | Calculator, Drug Dose |
| Applicant | Voluntis, S.A. 22 Quai Gallieni Suresnes, FR 92150 |
| Contact | Kevin Howard |
| Correspondent | Kevin Howard Voluntis, S.A. 22 Quai Gallieni Suresnes, FR 92150 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-06-04 |