The following data is part of a premarket notification filed by Voluntis S.a. with the FDA for Insulia Diabetes Management Companion.
| Device ID | K161433 |
| 510k Number | K161433 |
| Device Name: | Insulia Diabetes Management Companion |
| Classification | Calculator, Drug Dose |
| Applicant | VOLUNTIS S.A. 58, AVENUE DE WAGRAM Paris, FR 75017 |
| Contact | Raffi Krikorian |
| Correspondent | Raffi Krikorian VOLUNTIS S.A. 2, RUE DES BOURETS Suresnes, FR 92150 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-24 |
| Decision Date | 2016-11-09 |
| Summary: | summary |