510(k) K171113 ยท HIH Hysteroscope (And Accessories)
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
| Applicant | Lina Medical Aps, Glostrup, DK |
| Decision | Substantially Equivalent, Jan 4, 2018 |
| Received | Apr 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171113
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.