510(k) K160341 ยท HEX Colposcope (And Colpomicroscope)
Colposcope System
| Applicant | Xuzhou Kernel Medical Equipment Co., Ltd., Xuzhou, CN |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | Feb 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160341
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.