The following data is part of a premarket notification filed by Vitrolife A/s with the FDA for Kidscore D3.
| Device ID | K182798 |
| 510k Number | K182798 |
| Device Name: | KIDScore D3 |
| Classification | Embryo Image Assessment System, 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 | PBH |
| CFR Regulation Number | 884.6195 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-02 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712714675317 | K182798 | 000 |