PENTAX Medical Video Upper GI Scopes (EG Family)

Gastroscope 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 Upper Gi Scopes (eg Family).

Pre-market Notification Details

Device IDK190799
501k NumberK190799
Device Name:PENTAX Medical Video Upper GI Scopes (EG Family)
ClassificationGastroscope 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 CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-28
Decision Date2019-11-12

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