PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)

Endoscopic Ultrasound System, Gastroenterology-urology

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 Eg-j10u Endoscopic Ultrasound System - Eg34-j10u Ultrasound Upper Gi Video Scope (convex Array Type), Eg36-j10ur Ultrasound Upper Gi Video Scope (radial Array Type), Eg38-j10ut Ultrasound Upper Gi Video Scope (convex Array Type).

Pre-market Notification Details

Device IDK200090
510k NumberK200090
Device Name:PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
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 CodeODG  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2020-07-23

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