The following data is part of a premarket notification filed by Sedecal., Sa. with the FDA for Soltus 500.
| Device ID | K192936 |
| 510k Number | K192936 |
| Device Name: | Soltus 500 |
| Classification | System, X-ray, Mobile |
| Applicant | Sedecal., SA. C/ Pelaya, 9-13 Pol. Ind. Rio De Janerio Algete, ES 28110 |
| Contact | Ma Luisa Gomez De Aguero |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046002463 | K192936 | 000 |
| 08436046002456 | K192936 | 000 |
| 08436046002449 | K192936 | 000 |
| 08436046002562 | K192936 | 000 |
| 08436046002555 | K192936 | 000 |
| 08436046002548 | K192936 | 000 |
| 08436046002531 | K192936 | 000 |