510(k) K170839 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
RAPID Web
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Mar 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170839
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.