510(k) K161701 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
CARTO ENT System
| Applicant | Biosense Webster, Diamond Bar CA, US |
| Decision | Substantially Equivalent, Oct 24, 2016 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161701
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.