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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 DEN120015
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 Received08/24/2012
Decision Date 06/06/2014
Decision an (AN)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Post-NSE
Reviewed by Third Party No
Combination Product No
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