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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, drug dose
510(k) Number K202596
Device Name Insulia Diabetes Management Companion
Voluntis, S.A.
22 Quai Gallieni
Suresnes,  FR 92150
Applicant Contact Kevin Howard
Voluntis, S.A.
22 Quai Gallieni
Suresnes,  FR 92150
Correspondent Contact Kevin Howard
Regulation Number868.1890
Classification Product Code
Date Received09/08/2020
Decision Date 06/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No