510(k) K181637 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 9, 2019 |
| Received | Jun 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181637
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.