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510(k) K192841

Device
InPen System
Applicant
Companion Medical, Inc.
510(k) number
K192841
Product code
NDC  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-10
Date received
2019-10-03
Regulation
868.1890
Classification name
Calculator, Drug Dose
Medical specialty
Anesthesiology
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jasper Benke
Address
11011 Via Frontera Suite D San Diego CA US 92127 92127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NDC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254102GlucommanderGlytec, LLC2026-05-27
K260910EndoTool IV Cloud 1.0Glooko, Inc.2026-05-01
K253512MiniMed Go AppMedtronic Minimed2026-01-08
K253281UpDocUpdoc, Inc.2025-12-23
K252104T1D1Comerge AG2025-08-20
K241088EndoTool IV (3.1)Monarch Medical Technologies2024-12-11
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed2024-11-12
K242066iSage RxAmalgam Rx, Inc.2024-08-21
K232451Insulia Bolus CompanionVoluntis Sa.2023-12-12
K230813BlueStar and BlueStar RxWelldoc, Inc.2023-07-28
K221924Digital RoutinesGnc Holdings, LLC2023-03-15
K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC2021-10-28
K203434BlueStar RxWelldoc, Inc.2021-09-08
K202596Insulia Diabetes Management CompanionVoluntis Sa.2021-06-04
K201619EndoTool IV SystemMonarch Medical Technologies, LLC2020-08-07

Legacy Summary#

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FDA Review#

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