Insulia Diabetes Management Companion

Calculator, Drug Dose

VOLUNTIS S.A.

The following data is part of a premarket notification filed by Voluntis S.a. with the FDA for Insulia Diabetes Management Companion.

Pre-market Notification Details

Device IDK161433
510k NumberK161433
Device Name:Insulia Diabetes Management Companion
ClassificationCalculator, Drug Dose
Applicant VOLUNTIS S.A. 58, AVENUE DE WAGRAM Paris,  FR 75017
ContactRaffi Krikorian
CorrespondentRaffi Krikorian
VOLUNTIS S.A. 2, RUE DES BOURETS Suresnes,  FR 92150
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-24
Decision Date2016-11-09
Summary:summary

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