510(k) K160381 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
TE7 Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 9, 2016 |
| Received | Feb 10, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160381
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.