510(k) K153247 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Fusion Compact Navigation System
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Feb 18, 2016 |
| Received | Nov 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153247
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.