510(k) K181034 ยท HEX Colposcope (And Colpomicroscope)
Pocket Colposcope System
| Applicant | Hadleigh Health Technologies, LLC, San Rafael CA, US |
| Decision | Substantially Equivalent, Sep 21, 2018 |
| Received | Apr 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181034
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.