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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 embryo image assessment system, assisted reproduction
De Novo Number DEN120015
510(K) Number K120427
Device Name EEVA 2.0
Requester
AUXOGYN, INC.
1171 barroilhet drive
hillsborough,  CA  94010
Contact cindy domecus
Regulation Number884.6195
Classification Product Code
PBH  
Date Received08/24/2012
Decision Date 06/06/2014
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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