The following data is part of a premarket notification filed by Unisense Fertilitech A/s with the FDA for Embryoviewer Software.
| Device ID | K133712 |
| 510k Number | K133712 |
| Device Name: | EMBRYOVIEWER SOFTWARE |
| Classification | Accessory, Assisted Reproduction |
| Applicant | UNISENSE FERTILITECH A/S TUEAGER 1 Aarhus N, DK Dk-8200 |
| Contact | Henrik Wahlgren |
| Correspondent | Henrik Wahlgren UNISENSE FERTILITECH A/S TUEAGER 1 Aarhus N, DK Dk-8200 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-05 |
| Decision Date | 2014-08-08 |
| Summary: | summary |