510(k) K240276 · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
| Applicant | Given Imaging Ltd. (D.B.A. Medtronic), Yoqneam Northern, IL |
| Decision | Substantially Equivalent, May 10, 2024 |
| Received | Jan 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240276
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.