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QCC — Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Class II

FDA Device Classification

Classification Details

Product Code
QCC
Device Class
Class II
Regulation Number
862.1358
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

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