510(k) K132861 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Samsung Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 4, 2013 |
| Received | Sep 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132861
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.