510(k) K022980 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
| Applicant | Given Imaging , Ltd., Yoqneaam, IL |
| Decision | Substantially Equivalent, Feb 27, 2003 |
| Received | Sep 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022980
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.