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 IDK202596
510k NumberK202596
Device Name:Insulia Diabetes Management Companion
ClassificationCalculator, Drug Dose
Applicant Voluntis, S.A. 22 Quai Gallieni Suresnes,  FR 92150
ContactKevin Howard
CorrespondentKevin Howard
Voluntis, S.A. 22 Quai Gallieni Suresnes,  FR 92150
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2021-06-04

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.