510(k) K151011 ยท HET Laparoscope, Gynecologic (And Accessories)
VISERA 4K UHD SYSTEM
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 1, 2015 |
| Received | Apr 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151011
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.