510(k) K233579 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SC1 Handheld Ultrasound Imaging system (Model: SC1)
| Applicant | Fcu Co., Ltd., Yuseong-Gu, KR |
| Decision | Substantially Equivalent, Jun 26, 2024 |
| Received | Nov 7, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233579
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.