510(k) K190187 ยท HEX Colposcope (And Colpomicroscope)
Gynescope System
| Applicant | Illumigyn , Ltd., Neve Ilan, IL |
| Decision | Substantially Equivalent, May 8, 2019 |
| Received | Feb 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190187
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.