510(k) K111450 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MIROCAM CAPSULE ENDOSCOPE SYSTEM
| Applicant | Intromedic Co., Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, May 18, 2012 |
| Received | May 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111450
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.