510(k) K210959 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Jun 24, 2021 |
| Received | Mar 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210959
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.