PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

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 Ultrasound Upper Gi Video Scope Eg34-j10u, Pentax Medical Ultrasound Upper Gi Video Scope Eg36-j10ur, Pentax Medical Ultrasound Upper Gi Video Scope Eg38-j10ut, Pentax Medical Ultrasound Video Bronchoscope Eb19-j10u.

Pre-market Notification Details

Device IDK203166
510k NumberK203166
Device Name:PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactWilliam Goeller
CorrespondentFumiaki Kanai
MIC International 4-1-17 Hongo Bunkyo-ku,  JP 113-0033
Product CodeODG  
Subsequent Product CodeEOQ
Subsequent Product CodeITX
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-23
Decision Date2020-12-30

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