510(k) K160078 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid T8
| Applicant | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Jan 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160078
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.