The following data is part of a premarket notification filed by Genea Biomedx Pty Ltd with the FDA for Geri Embryo Incubator And Geri Dish.
| Device ID | K180304 |
| 510k Number | K180304 |
| Device Name: | Geri Embryo Incubator 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 |
| Subsequent Product Code | MQK |
| Subsequent Product Code | MTX |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348265003048 | K180304 | 000 |