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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 K201476
Device Name DreaMed Advisor Pro
Applicant
DreaMed Diabetes Ltd
5 Mota Gur St
Petah Tikva,  IL 4952701
Applicant Contact Inbal Beinglass Peled
Correspondent
DreaMed Diabetes Ltd
5 Mota Gur St
Petah Tikva,  IL 4952701
Correspondent Contact Inbal Beinglass Peled
Regulation Number862.1358
Classification Product Code
QCC  
Date Received06/03/2020
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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