The following data is part of a premarket notification filed by Unisense Fertilitech A/s with the FDA for Embryoscope And Embryoslide.
| Device ID | K092183 |
| 510k Number | K092183 |
| Device Name: | EMBRYOSCOPE AND EMBRYOSLIDE |
| Classification | Accessory, Assisted Reproduction |
| Applicant | UNISENSE FERTILITECH A/S BRENDSTRUPGARDSVEJ 21F Arrhus, DK Dk-8200 |
| Contact | Mette Munch |
| Correspondent | Mette Munch UNISENSE FERTILITECH A/S BRENDSTRUPGARDSVEJ 21F Arrhus, DK Dk-8200 |
| Product Code | MQG |
| Subsequent Product Code | MQK |
| Subsequent Product Code | MTX |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2011-01-11 |
| Summary: | summary |