Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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 K142147
Device Name EEVA SYSTEM
Applicant
AUXOGYN, INC.
1490 O'BRIEN DRIVE, SUITE A
MENLO PARK,  CA  94025
Applicant Contact JULIA S ANASTAS
Correspondent
AUXOGYN, INC.
1490 O'BRIEN DRIVE, SUITE A
MENLO PARK,  CA  94025
Correspondent Contact JULIA S ANASTAS
Regulation Number884.6195
Classification Product Code
PBH  
Date Received08/05/2014
Decision Date 11/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01369446
NCT01635036
Reviewed by Third Party No
Combination Product No
-
-