510(k) K080640 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
M5 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Mar 21, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080640
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.