510(k) K041213 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
3DSCOPE
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Jul 22, 2004 |
| Received | May 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041213
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.