510(k) K182165 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Color Doppler Ultrasound System; Model: mEye1 and mEye2
| Applicant | Shenzhen Well.D Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Aug 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182165
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.