510(k) K061189 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Jun 1, 2006 |
| Received | Apr 28, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061189
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.