510(k) K160792 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
| Applicant | The Prometheus Group, Dover NH, US |
| Decision | Substantially Equivalent, Apr 15, 2016 |
| Received | Mar 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160792
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.