510(k) K091009 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
| Applicant | Esaote, S.p.A., Carmel IN, US |
| Decision | Substantially Equivalent, May 18, 2009 |
| Received | Apr 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091009
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.