510(k) DEN120015
- Device
- EEVA 2.0
- Applicant
- Auxogyn, Inc.
- 510(k) number
- DEN120015
- Product code
- PBH
- Decision
- Unknown (DENG)
- Decision date
- 2014-06-06
- Date received
- 2012-08-24
- Regulation
- 884.6195
- Classification name
- Embryo Image Assessment System, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- CINDY DOMECUS
- Address
- 1171 Barroilhet Dr. Hillsborough CA US 94010 94010
FDA Registration Numbers#
- 3042372505
- 3009107689
- 3042972064
Source Documents#
510(k) summary PDF not indicated by FDA