510(k) K211824 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HERA W9, HERA W10 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Sep 9, 2021 |
| Received | Jun 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211824
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.