510(k) K160343 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
| Applicant | Beijing East Whale Imaging Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Feb 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160343
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.