510(k) K163069 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
| Applicant | Olympus Medical Systems Corp., Hachioji, JP |
| Decision | Substantially Equivalent, Jan 19, 2017 |
| Received | Nov 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163069
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.