510(k) K210468 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SC1 Handheld Ultrasound Imaging System (Model: SC1)
| Applicant | Fcu Co., Ltd., Yuseong-Gu, KR |
| Decision | Substantially Equivalent, Jul 23, 2021 |
| Received | Feb 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210468
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.