510(k) K200655 · IYO System, Imaging, Pulsed Echo, Ultrasonic
FibroScan® 630
| Applicant | Echosens, Paris, FR |
| Decision | Substantially Equivalent, Jul 16, 2020 |
| Received | Mar 12, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200655
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.