510(k) K191072 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
7410 Ultrasound System (MyLabSigma)
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Jun 10, 2019 |
| Received | Apr 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191072
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.