510(k) K083001 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
M5 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Nanshan, Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Oct 22, 2008 |
| Received | Oct 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083001
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.