Cleared Traditional

Insulia Diabetes Management Companion

K170669 · Voluntis Sa. · General Hospital
Jun 2017
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K170669 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 June 19, 2017, 105 days after receiving the submission on March 6, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K170669 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2017
Decision Date June 19, 2017
Days to Decision 105 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