510(k) K223564 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
X-CUBE 50, X-CUBE 60
| Applicant | Alpinion Medical Systems Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Apr 17, 2023 |
| Received | Nov 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223564
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.