510(k) K150618 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
PENTAX Medical EPK-i7010 Video Processor with GI Family
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Nov 24, 2015 |
| Received | Mar 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150618
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.