510(k) K123864 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
| Applicant | Given Imaging , Ltd., Yokneam (P.O.Box 258), IL |
| Decision | Substantially Equivalent, Aug 12, 2013 |
| Received | Dec 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123864
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.