510(k) K190449 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190449
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.