510(k) K252237 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EdgeFlow UW20
| Applicant | Edgecare, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Apr 17, 2026 |
| Received | Jul 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252237
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.