510(k) K153620 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Enovare Ultrasound System
| Applicant | Oreon Technologies, Inc., Harrytown NY, US |
| Decision | Substantially Equivalent, May 5, 2016 |
| Received | Dec 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153620
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.