Skip to contentDe Novo DEN120015
- Device
- EEVA 2.0
- Contact
- cindy domecus
- De Novo number
- DEN120015
- Product code
- PBH
- Regulation
- 884.6195
- Classification name
- embryo image assessment system, assisted reproduction
- Decision
- granted (DENG)
- Decision date
- 2014-06-06
- Date received
- 2012-08-24
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PBH
- Device name
- Embryo Image Assessment System, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.6195
- Implant
- N
- Life sustain/support
- N