510(k) K100363 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRA DCI MODEL 5000
| Applicant | Ultrasound Medical Devices, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100363
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.