510(k) K042361 ยท IZL System, X-Ray, Mobile
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
| Applicant | Sedecal USA, Inc., Deer Field IL, US |
| Decision | Substantially Equivalent, Sep 29, 2004 |
| Received | Aug 31, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042361
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.