510(k) K875341 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
EDEC 60 R/F
| Applicant | Electromed Intl., Ltd., Canada, CA |
| Decision | Substantially Equivalent, Feb 1, 1988 |
| Received | Dec 30, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875341
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.