510(k) K162290 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MyLabSix CrystaLine
| Applicant | Esaote, S.p.A., Genova, IT |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Aug 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162290
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.