510(k) K190772 ยท IZI System, X-Ray, Angiographic
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Mar 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190772
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.