510(k) K211291 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Jul 19, 2021 |
| Received | Apr 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211291
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.