510(k) K111864 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
E-CUBE 9
| Applicant | Alpinion Medical Systems Co., Ltd., Kirkland WA, US |
| Decision | Substantially Equivalent, Jul 15, 2011 |
| Received | Jun 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111864
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.