The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Mobilediagnost Wdr 2.2.
| Device ID | K191813 |
| 510k Number | K191813 |
| Device Name: | MobileDiagnost WDR 2.2 |
| Classification | System, X-ray, Mobile |
| Applicant | Sedecal SA C/Pelaya, 9 - 13 Pol. Ind. Rio De Janeiro Algete, ES 28110 |
| Contact | Maria Luisa Gomez De Aguero |
| Correspondent | Laura Green Laura Green, LLC. 227 East 284th Street Willowick, OH 44095 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-05 |
| Decision Date | 2019-08-02 |