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Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

FDA product code QCC · 4 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1358
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-18 – 2023-10-03

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.

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