Cleared Traditional

Insulia Diabetes Management Companion

K161433 · Voluntis Sa. · General Hospital
Nov 2016
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K161433 is an FDA 510(k) clearance for the Insulia Diabetes Management Companion, 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 review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K161433 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890