510(k) K122311 ยท HEX Colposcope (And Colpomicroscope)
GC-3000E DIGITAL COLPOSCOPE
| Applicant | Shenzhen Goldcare Meditech Co., Ltd., San Marino CA, US |
| Decision | Substantially Equivalent, Sep 18, 2013 |
| Received | Aug 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122311
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.