The following data is part of a premarket notification filed by Vitrolife A/s with the FDA for Embryoscope+.
| Device ID | K173264 |
| 510k Number | K173264 |
| Device Name: | EmbryoScope+ |
| Classification | Accessory, 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 Dk-8260 Viby J, DK |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-11 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712714664502 | K173264 | 000 |
| 05712714604010 | K173264 | 000 |