510(k) K203391 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 23, 2021 |
| Received | Nov 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203391
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.