510(k) K170210 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
| Applicant | Given Imaging , Ltd., Yoqneam, IL |
| Decision | Substantially Equivalent, Sep 1, 2017 |
| Received | Jan 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170210
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.