510(k) K200136 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Shear Wave Quantificational Ultrasound Diagnostic System
| Applicant | Wuxi Hisky Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Mar 17, 2020 |
| Received | Jan 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200136
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.