The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Sedecal Mobile Digital Diagnostic X-ray.
| Device ID | K101517 |
| 510k Number | K101517 |
| Device Name: | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL S.A. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. SEDECAL S.A. 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 | 2010-06-02 |
| Decision Date | 2011-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436046002609 | K101517 | 000 |
| 08436046002593 | K101517 | 000 |
| 08436046002586 | K101517 | 000 |
| 08436046002579 | K101517 | 000 |