510(k) K161439 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
E-CUBE 11
| Applicant | Alpinion Medical Systems Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Sep 21, 2016 |
| Received | May 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161439
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.