PENTAX Medical EPK-i7010 Video Processor With EB Family Of Scopes

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 Video Processor With Eb Family Of Scopes.

Pre-market Notification Details

Device IDK173679
510k NumberK173679
Device Name:PENTAX Medical EPK-i7010 Video Processor With EB Family Of Scopes
ClassificationEndoscope, Accessories, Image Post-processing For Color Enhancement
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactJames W. Monroe
CorrespondentWilliam Goeller
PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645
Product CodePEA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2018-07-03
Summary:summary

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