DreaMed Advisor Pro

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

DreaMed Diabetes Ltd

The following data is part of a premarket notification filed by Dreamed Diabetes Ltd with the FDA for Dreamed Advisor Pro.

Pre-market Notification Details

Device IDK201476
510k NumberK201476
Device Name:DreaMed Advisor Pro
ClassificationInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Applicant DreaMed Diabetes Ltd 5 Mota Gur St Petah Tikva,  IL 4952701
ContactInbal Beinglass Peled
CorrespondentInbal Beinglass Peled
DreaMed Diabetes Ltd 5 Mota Gur St Petah Tikva,  IL 4952701
Product CodeQCC  
CFR Regulation Number862.1358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-03
Decision Date2020-08-28

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