510(k) K160275 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Fuse Endoscopic System with FuseBox Processor
| Applicant | Endochoice, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Aug 1, 2016 |
| Received | Feb 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160275
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.