510(k) K070475 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
| Applicant | Given Imaging , Ltd., Calgary, Alberta, CA |
| Decision | Substantially Equivalent, May 7, 2007 |
| Received | Feb 20, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070475
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.