510(k) K190447 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
7400 Ultrasound Systems
| Applicant | Navigant Consulting - on Behalf of Esaote S.P.A., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 1, 2019 |
| Received | Feb 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190447
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.