510(k) K201828 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson SWIFT, Voluson SWIFT+
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Oct 11, 2020 |
| Received | Jul 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201828
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.