510(k) K111302 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLABSEVEN, MYLABALPHA
| Applicant | Esaote, S.p.A., Carmel IN, US |
| Decision | Substantially Equivalent, Jul 22, 2011 |
| Received | May 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111302
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.