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510(k) K192841

InPen System by Companion Medical, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2020
Date Received
October 3, 2019
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 Companion Medical, Inc.

  • K201337 — InPen System (June 18, 2020)
  • K190487 — InPen Dose Calculator (February 18, 2020)
  • K181327 — InPen Dose Calculator (July 6, 2018)
  • K160629 — InPen (July 26, 2016)

Other clearances for product code NDC

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  • K252104 — T1D1 (August 20, 2025)
  • K241088 — EndoTool IV (3.1) (December 11, 2024)
  • 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)