510(k) K151086 ยท FFX System, Gastrointestinal Motility (Electrical)
ManoScan System
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, Apr 28, 2016 |
| Received | Apr 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151086
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.