2 devices · 2 companies · 2018 to 2019
Product code QCC: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
2 devices under product code QCC, 2018 to 2019, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals. 21 CFR 862.1358, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| DreaMed Advisor ProK191370 · 510(k) | DreaMed Diabetes Ltd | Clinical Chemistry | database entry | |
| DreaMed Advisor ProDEN170043 · De Novo | DreaMed Diabetes, Ltd. | Clinical Chemistry | database entry |
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