510(k) K190444 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HERA I10 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Hongcheon-Gun, KR |
| Decision | Substantially Equivalent, May 22, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190444
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.