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510(k) K202596

Insulia Diabetes Management Companion by Voluntis Sa. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
September 8, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Voluntis Sa.

  • K250022 — HeroTracker Sense (June 30, 2025)
  • K232451 — Insulia Bolus Companion (December 12, 2023)
  • K172177 — Insulia Diabetes Management Companion (November 7, 2017)
  • K170669 — Insulia Diabetes Management Companion (June 19, 2017)
  • K161433 — Insulia Diabetes Management Companion (November 9, 2016)

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  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K242066 — iSage Rx (August 21, 2024)
  • K232451 — Insulia Bolus Companion (December 12, 2023)
  • K230813 — BlueStar and BlueStar Rx (July 28, 2023)
  • K221924 — Digital Routines (March 15, 2023)
  • K211160 — EndoTool SubQ 2.1 (October 28, 2021)