The following data is part of a premarket notification filed by Fmi Medical Systems Inc. with the FDA for Cura 778.
| Device ID | K192590 |
| 510k Number | K192590 |
| Device Name: | CURA 778 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | FMI Medical Systems Inc. 29001 Solon Road, Unit A Solon, OH 44139 |
| Contact | Dazhuang Meng |
| Correspondent | Dazhuang Meng FMI Medical Systems Inc. 29001 Solon Road, Unit A Solon, OH 44139 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-03-05 |