510(k) K193007 ยท HIH Hysteroscope (And Accessories)
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 17, 2020 |
| Received | Oct 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193007
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.