510(k) K213523 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
X-CUBE i8, X-CUBE i9
| Applicant | Alpinion Medical Systems Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Nov 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213523
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.