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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 continuous glucose monitor retrospective data analysis software
De Novo Number DEN140016
Device Name STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
Requester
dexcom, inc.
6340 sequence dr.
san diego,  CA  92121
Contact andrew balo
Regulation Number862.2120
Classification Product Code
PHV  
Date Received04/22/2014
Decision Date 08/19/2014
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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