K161433 is an FDA 510(k) clearance for the Insulia Diabetes Management Companion. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Voluntis Sa. (Paris, FR). The FDA issued a Cleared decision on November 9, 2016, 169 days after receiving the submission on May 24, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K161433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2016 |
| Decision Date | November 09, 2016 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |