510(k) K243479 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EchoGuide (Version 1)
| Applicant | Sonavex, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Apr 23, 2025 |
| Received | Nov 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243479
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.