510(k) K101250 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
| Applicant | Given Imaging , Ltd., Yoqneaam, IL |
| Decision | Substantially Equivalent, Mar 7, 2011 |
| Received | May 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101250
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.