510(k) K171661 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Scopis Extended Instrument Set EM
| Applicant | Scopis GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Sep 27, 2017 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171661
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.