510(k) K133905 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6200 / 6250 ULTRASOUND SYSTEM
| Applicant | Esaote, S.p.A., Indianpolis IN, US |
| Decision | Substantially Equivalent, Apr 15, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133905
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.