510(k) K091518 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Mcube Technology Co., Ltd., Flintville TN, US |
| Decision | Substantially Equivalent, Jun 18, 2009 |
| Received | May 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091518
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.