510(k) K153424 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
E-CUBE i7
| Applicant | Alpinion Medical Systems Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Feb 26, 2016 |
| Received | Nov 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153424
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.