The following data is part of a premarket notification filed by Sedecal Usa, Inc. with the FDA for Digital Portable X-ray Units, Model Sp-hf-4.0 D.
| Device ID | K042361 |
| 510k Number | K042361 |
| Device Name: | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-09-29 |
| Summary: | summary |