510(k) K201965 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
| Applicant | CHISON Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Mar 2, 2021 |
| Received | Jul 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201965
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.