510(k) K103088 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | Oct 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103088
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.