510(k) K143264 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
H60 V2.00 Diagnostic Ultrasound System
| Applicant | Samsung Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Dec 9, 2014 |
| Received | Nov 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143264
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.