510(k) K212021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6430 MyLabX75, 6430 MyLab XPro75
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Sep 16, 2021 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212021
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.