510(k) K183191 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6420 Ultrasound System
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Nov 19, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183191
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.