The following data is part of a premarket notification filed by Auxogyn, Inc. with the FDA for Eeva Dish (with 12 Microwells).
| Device ID | K141663 |
| 510k Number | K141663 |
| Device Name: | EEVA DISH (WITH 12 MICROWELLS) |
| Classification | Labware, 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 | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2014-07-22 |
| Summary: | summary |