510(k) K083882 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLABFIVE
| Applicant | Esaote Europe B.V., Carmel IN, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083882
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.