510(k) K200216 ยท HET Laparoscope, Gynecologic (And Accessories)
4K UHD Camera System
| Applicant | Scivita Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Aug 21, 2020 |
| Received | Jan 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200216
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.