510(k) K161491 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Scopis Hybrid Navigation System EM
| Applicant | Scopis GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Feb 9, 2017 |
| Received | Jun 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161491
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.