510(k) K942243 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
IMEX 8000 PERSONAL CASCULAR LAB
| Applicant | Imex Medical Systems, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Nov 3, 1995 |
| Received | May 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942243
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.