510(k) K090557 ยท NSI System, Imaging, Esophageal, Wireless, Capsule
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
| Applicant | Given Imaging , Ltd., Yoqneaam, IL |
| Decision | Substantially Equivalent, Sep 28, 2009 |
| Received | Mar 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090557
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.