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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insulin pump therapy adjustment calculator for healthcare professionals
Regulation Description Insulin therapy adjustment device.
Definition An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.
Product CodeQCC
Regulation Number 862.1358
Device Class 2


Premarket Reviews
ManufacturerDecision
DREAMED DIABETES, LTD.
  SUBSTANTIALLY EQUIVALENT 2

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