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510(k) K232451

Insulia Bolus Companion by Voluntis Sa. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2023
Date Received
August 14, 2023
Clearance Type
Traditional
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.

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  • K170669 — Insulia Diabetes Management Companion (June 19, 2017)
  • K161433 — Insulia Diabetes Management Companion (November 9, 2016)

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