Pentax Medical Video Duodenoscope ED32-i10

Duodenoscope And Accessories, Flexible/rigid

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 Video Duodenoscope Ed32-i10.

Pre-market Notification Details

Device IDK202365
510k NumberK202365
Device Name:Pentax Medical Video Duodenoscope ED32-i10
ClassificationDuodenoscope And Accessories, Flexible/rigid
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 CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-04-01

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