510(k) K192319 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, Dec 10, 2019 |
| Received | Aug 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192319
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.