510(k) K895645 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Biosound, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 6, 1990 |
| Received | Sep 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895645
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.