510(k) K032405 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
GIVEN DIAGNOSTIC SYSTEM
| Applicant | Given Imaging , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Oct 29, 2003 |
| Received | Aug 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032405
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.