510(k) K091405 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
| Applicant | Given Imaging , Ltd., Yoqneaam, IL |
| Decision | Substantially Equivalent, Jul 29, 2009 |
| Received | May 12, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091405
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.