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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device continuous glucose monitor informed insulin dose calculator
Definition A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.
Product CodeQRX
Regulation Number 862.1358
Device Class 2


Premarket Reviews
ManufacturerDecision
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem: Medication Error 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 1 1

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