510(k) K190039 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EchoSure Diagnostic Ultrasound System
| Applicant | Sonavex, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Mar 8, 2019 |
| Received | Jan 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190039
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.