510(k) K843443 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
EDEC-100
| Applicant | Electromed Intl., Ltd., Willoughby OH, US |
| Decision | Substantially Equivalent, Mar 1, 1985 |
| Received | Sep 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843443
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.