510(k) K212851 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
EchoSK and EchoSGyn modules for EchoS Family devices
| Applicant | Echolight S.P.A, Lecce, IT |
| Decision | Substantially Equivalent, Mar 16, 2022 |
| Received | Sep 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212851
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.