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 Number | 884.6195
|
Classification Product Code |
|
Date Received | 08/24/2012 |
Decision Date | 06/06/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|