510(k) K954220 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EUB-8000
| Applicant | Hitachi Medical Corp. of America, Tarrytown NY, US |
| Decision | Substantially Equivalent, May 7, 1997 |
| Received | Sep 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954220
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.