510(k) K092278 ยท HIH Hysteroscope (And Accessories)
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Sep 29, 2009 |
| Received | Jul 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092278
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.