K142147 is an FDA 510(k) clearance for the EEVA SYSTEM, a Embryo Image Assessment System, Assisted Reproduction (Class II — Special Controls, product code PBH), submitted by Auxogyn, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 24, 2014, 111 days after receiving the submission on August 5, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6195.
| 510(k) Number | K142147 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 2014 |
| Decision Date | November 24, 2014 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBH — Embryo Image Assessment System, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6195 |
| Definition | 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 . |