510(k) K170018 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
StealthStationTM S8 ENT Software
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, May 19, 2017 |
| Received | Jan 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170018
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.