The following data is part of a premarket notification filed by Auxogyn, Inc. with the FDA for Eeva System.
| Device ID | K142147 |
| 510k Number | K142147 |
| Device Name: | EEVA SYSTEM |
| Classification | Embryo Image Assessment System, Assisted Reproduction |
| Applicant | AUXOGYN, INC. 1490 O'BRIEN DRIVE, SUITE A Menlo Park, CA 94025 |
| Contact | Julia S Anastas |
| Correspondent | Julia S Anastas AUXOGYN, INC. 1490 O'BRIEN DRIVE, SUITE A Menlo Park, CA 94025 |
| Product Code | PBH |
| CFR Regulation Number | 884.6195 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2014-11-24 |
| Summary: | summary |