510(k) K182594 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
E-CUBE i7
| Applicant | Alpinion Medical Systems Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Jan 24, 2019 |
| Received | Sep 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182594
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.