510(k) K190805 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190805
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.