510(k) K873845 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SIM 4000I
| Applicant | Ote-Biomedica Elettronica S.P.A, Cambridge MA, US |
| Decision | Substantially Equivalent, Apr 7, 1988 |
| Received | Sep 22, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873845
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.