510(k) K101149 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
| Applicant | Ge Vingmed Ultrasound AS, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Oct 13, 2010 |
| Received | Apr 23, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101149
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.