510(k) K162845 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 15, 2016 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162845
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.