510(k) K191792 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Versana Balance
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 9, 2019 |
| Received | Jul 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191792
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.