510(k) K234090 · IZI System, X-Ray, Angiographic
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
| Applicant | Surgvision GmbH, Munich, DE |
| Decision | Substantially Equivalent, Mar 20, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234090
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.