510(k) K210068 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Apr 9, 2021 |
| Received | Jan 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210068
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.