510(k) K183053 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Olympus Small Intestinal Capsule Endoscope System
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Mar 5, 2019 |
| Received | Nov 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183053
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.