510(k) K170438 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MiroCam Capsule Endoscope System
| Applicant | Intromedic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 30, 2018 |
| Received | Feb 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170438
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.