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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insulin pump therapy adjustment calculator for healthcare professionals
510(k) Number K191370
Device Name DreaMed Advisor Pro
Applicant
DreaMed Diabetes Ltd
5 Mota Gur Street
petah tikva,  IL 4952701
Applicant Contact eran atlas
Correspondent
DreaMed Diabetes Ltd
5 Mota Gur Street
petah tikva,  IL 4952701
Correspondent Contact eran j. atlas
Regulation Number862.1358
Classification Product Code
QCC  
Date Received05/22/2019
Decision Date 07/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01308164
Reviewed by Third Party No
Combination Product No
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