510(k) K192822 ยท HIH Hysteroscope (And Accessories)
Benesta Hysteroscope
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, Sep 9, 2020 |
| Received | Oct 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192822
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.