DreaMed Advisor Pro

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

DreaMed Diabetes, Ltd.

The following data is part of a De Novo classification by Dreamed Diabetes, Ltd. with the FDA for Dreamed Advisor Pro.

Pre-market Notification Details

DeNovo IDDEN170043
Device Name:DreaMed Advisor Pro
ClassificationInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Applicant DreaMed Diabetes, Ltd. 3 Shimshon St. Petah Tikva, Pob 3271,  IL 4952701
ContactEran Atlas
Product CodeQCC  
CFR Regulation Number862.1358 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
Date Received2017-08-17
Decision Date2018-06-12
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
07290017735016 DEN170043 000

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