510(k) K180409 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HS40 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Gangwon-Do, KR |
| Decision | Substantially Equivalent, May 11, 2018 |
| Received | Feb 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180409
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.