510(k) K200542 ยท OWN Confocal Optical Imaging
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Mar 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200542
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.