510(k) K163077 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E9, LOGIQ E9 XDClear 2.0
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Nov 3, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163077
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.