PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope

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 Ed-3490tk, Video Duodenoscope, Pentax Medical Ed34-i10t, Video Duodenoscope.

Pre-market Notification Details

Device IDK181522
510k NumberK181522
Device Name:PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-11
Decision Date2018-07-09
Summary:summary

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