510(k) K180912 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
TE7/TE5 Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 30, 2018 |
| Received | Apr 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180912
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.