510(k) K897042 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
| Applicant | Hitachi Medical Corp. of America, Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 13, 1990 |
| Received | Dec 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897042
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.