510(k) K192253 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SonicEye Dual-Array Ultrasound System
| Applicant | Sonivate Medical, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Feb 25, 2020 |
| Received | Aug 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192253
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.