The following data is part of a premarket notification filed by Genea Biomedx Pty Ltd with the FDA for Geri Embryo Incubator With Geri Connect And Geri Assess Software, And Geri Dish.
| Device ID | K180188 |
| 510k Number | K180188 |
| Device Name: | Geri Embryo Incubator With Geri Connect And Geri Assess Software, And Geri Dish |
| Classification | Accessory, Assisted Reproduction |
| Applicant | Genea Biomedx Pty Ltd Level 2, 321 Kent Street Sydney, AU 2000 |
| Contact | Kea Dent |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348265003086 | K180188 | 000 |
| 09348265003079 | K180188 | 000 |
| 09348265003024 | K180188 | 000 |