510(k) K063121 ยท EHD Unit, X-Ray, Extraoral With Timer
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
| Applicant | Genoray Co., Ltd., Flintville TN, US |
| Decision | Substantially Equivalent, Jan 11, 2007 |
| Received | Oct 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063121
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.