510(k) K060805 ยท NSI System, Imaging, Esophageal, Wireless, Capsule
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
| Applicant | Given Imaging , Ltd., Yokneam (P.O.Box 258), IL |
| Decision | Substantially Equivalent, May 24, 2006 |
| Received | Mar 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060805
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.