510(k) K212100 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Kosmos
| Applicant | EchoNous, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Aug 6, 2021 |
| Received | Jul 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2024 | Echonous Inc Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.