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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name insulin pump therapy adjustment calculator for healthcare professionals
De Novo Number DEN170043
Device Name DreaMed Advisor Pro
DreaMed Diabetes, Ltd.
3 shimshon st.
petah tikva, pob 3271,  IL 4952701
Contact eran atlas
Regulation Number862.1358
Classification Product Code
Date Received08/17/2017
Decision Date 06/12/2018
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct