510(k) K190797 ยท HIH Hysteroscope (And Accessories)
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
| Applicant | Reed Medical (Zhejiang) Co., Ltd., Pinghu, CN |
| Decision | Substantially Equivalent, Nov 18, 2019 |
| Received | Mar 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190797
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.