510(k) K200723 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Mar 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200723
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.