510(k) K221093 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
X-CUBE 70, X-CUBE 90
| Applicant | Alpinion Medical Systems Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Oct 14, 2022 |
| Received | Apr 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221093
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.