The following data is part of a premarket notification filed by Sedecal S.a. with the FDA for Portable X-ray Units; Models Sp-hf-2.8 & Sp-hf-4.0.
| Device ID | K020436 |
| 510k Number | K020436 |
| Device Name: | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL S.A. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-08 |
| Decision Date | 2002-02-22 |
| Summary: | summary |