510(k) K063259 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Sep 14, 2007 |
| Received | Oct 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063259
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.