• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name embryo image assessment system, assisted reproduction
510(k) Number K120427
Device Name EEVA 2.0
Original Applicant
1171 barroilhet drive
hillsborough,  CA  94010
Original Contact cindy domecus
Regulation Number884.6195
Classification Product Code
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