The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Proteus Xr/f, Models St And Et, Multirad And Multirad Net Radiographic Systems.
| Device ID | K203537 |
| 510k Number | K203537 |
| Device Name: | Proteus XR/f, Models ST And ET, Multirad And Multirad NET Radiographic Systems |
| Classification | System, X-ray, Stationary |
| Applicant | SEDECAL SA C/ Pelaya, 9-13 Pol. Ind. Rio De Janeiro Algete, ES 28110 |
| Contact | Ma Luisa Gomez De Aguero |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-03 |
| Decision Date | 2021-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046003033 | K203537 | 000 |
| 08436046003026 | K203537 | 000 |