510(k) K134005 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MIROCAM CAPSULE ENDOSCOPE SYSTEM
| Applicant | Intromedic Co., Ltd., Guro-Gu , Seoul, KR |
| Decision | Substantially Equivalent, Jul 9, 2014 |
| Received | Dec 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K134005
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.