510(k) K190786 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Eye Prime
| Applicant | Ellex Medical Pty, Ltd., Mawson Lakes, AU |
| Decision | Substantially Equivalent, Apr 11, 2019 |
| Received | Mar 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190786
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.