510(k) K210438 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Versana Premier
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Sep 10, 2021 |
| Received | Feb 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210438
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.