510(k) K230991 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
| Applicant | Given Imaging Ltd. (Medtronic), Yoqneam Northern, IL |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | Apr 6, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230991
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.