510(k) K153277 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6200 Ultrasound System and 6250 Ultrasound System
| Applicant | Esaote, S.p.A., Genova, IT |
| Decision | Substantially Equivalent, May 4, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153277
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.