The following data is part of a premarket notification filed by Voluntis S.a. with the FDA for Insulia Diabetes Management Companion.
| Device ID | K170669 |
| 510k Number | K170669 |
| 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. 58, Avenue De Wagram Paris, FR 75017 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-06 |
| Decision Date | 2017-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760261310023 | K170669 | 000 |
| 03760261310016 | K170669 | 000 |
| 03760261310009 | K170669 | 000 |