The following data is part of a premarket notification filed by Vitrolife A/s with the FDA for Embryoslide+ Ic8 Dish.
| Device ID | K213869 |
| 510k Number | K213869 |
| Device Name: | EmbryoSlide+ Ic8 Dish |
| Classification | Labware, Assisted Reproduction |
| Applicant | Vitrolife A/S Jens Juuls Vej 20 Viby J, DK 8260 |
| Contact | Belinda Dueholm |
| Correspondent | Belinda Dueholm Vitrolife A/S Jens Juuls Vej 20 Viby J, DK 8260 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712714000041 | K213869 | 000 |