The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Gx-ivf, Gx-tl, Gx-mops Plus.
| Device ID | K202862 |
| 510k Number | K202862 |
| Device Name: | Gx-IVF, Gx-TL, Gx-MOPS PLUS |
| Classification | Media, Reproductive |
| Applicant | Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE 42132 |
| Contact | Sarah Hood Hagberg |
| Correspondent | Sarah Hood Hagberg Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE 42132 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-05-14 |