510(k) K173679 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Jul 3, 2018 |
| Received | Dec 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173679
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.