510(k) K193518 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
KOSMOS
| Applicant | EchoNous, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193518
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.