PENTAX Medical EPK-i7010 And PENTAX EPK-i5010 Video Processors With GI Family

Endoscope, Accessories, Image Post-processing For Color Enhancement

PENTAX Of America, Inc.

The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Epk-i7010 And Pentax Epk-i5010 Video Processors With Gi Family.

Pre-market Notification Details

Device IDK191282
501k NumberK191282
Device Name:PENTAX Medical EPK-i7010 And PENTAX EPK-i5010 Video Processors With GI Family
ClassificationEndoscope, Accessories, Image Post-processing For Color Enhancement
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactWilliam Goeller
CorrespondentWilliam Goeller
PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
Product CodePEA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2019-11-08

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.