510(k) K181547 · IYO System, Imaging, Pulsed Echo, Ultrasonic
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
| Applicant | Echosens, Paris, FR |
| Decision | Substantially Equivalent, Jul 9, 2018 |
| Received | Jun 12, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181547
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.