The following data is part of a premarket notification filed by Voluntis S.a. with the FDA for Insulia Diabetes Management Companion.
| Device ID | K172177 |
| 510k Number | K172177 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760261310085 | K172177 | 000 |
| 03760261310078 | K172177 | 000 |
| 03760261310061 | K172177 | 000 |