510(k) K042960 ยท NSI System, Imaging, Esophageal, Wireless, Capsule
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
| Applicant | Given Imaging , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Oct 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042960
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.