510(k) DEN120015
DEN120015 is an FDA 510(k) premarket notification submitted by Auxogyn, Inc. for the device "EEVA 2.0". The FDA issued a decision of De Novo Granted on June 6, 2014. The device falls under product code PBH (Embryo Image Assessment System, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6195. Auxogyn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 6, 2014
- Date Received
- August 24, 2012
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Embryo Image Assessment System, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6195
- Review Panel
- OB
- Submission Type
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .