510(k) K192157 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6450 Ultrasound system
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Aug 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192157
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.