510(k) K201995 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CUBEScan BioCon-1100
| Applicant | Mcube Technology Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Aug 19, 2020 |
| Received | Jul 20, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201995
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.