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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name embryo image assessment system, assisted reproduction
510(k) Number K120427
Device Name EEVA 2.0
Original Applicant
AUXOGYN, INC.
1171 barroilhet drive
hillsborough,  CA  94010
Original Contact cindy domecus
Regulation Number884.6195
Classification Product Code
PBH  
Date Received02/13/2012
Decision Date 06/06/2014
Decision de novo petitions granted (AN)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type De Novo Petitions Granted
Clinical Trials NCT01369446
Reviewed by Third Party No
Expedited Review No
Combination Product No
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