510(k) K181292 · EOX Esophagoscope (Flexible Or Rigid)
PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
| Applicant | Cogentix Medical, Inc., Orangeburg NY, US |
| Decision | Substantially Equivalent, Nov 15, 2018 |
| Received | May 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181292
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.