510(k) K911584 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
| Applicant | Pie Medical Equipment B.V., Maastricht, NL |
| Decision | Substantially Equivalent, Oct 24, 1991 |
| Received | Apr 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911584
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.