510(k) K103025 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, May 13, 2011 |
| Received | Oct 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103025
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.