510(k) K163691 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HS70A Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Feb 22, 2017 |
| Received | Dec 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163691
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.