PEERSCOPE SYSTEM

Gastroscope And Accessories, Flexible/rigid

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Peerscope System.

Pre-market Notification Details

Device IDK131422
510k NumberK131422
Device Name:PEERSCOPE SYSTEM
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant ENDOCHOICE, INC. 2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) POB 3161 Caesarea,  IL 38900
ContactTamar Fuerst
CorrespondentTamar Fuerst
ENDOCHOICE, INC. 2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) POB 3161 Caesarea,  IL 38900
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-16
Decision Date2013-10-10
Summary:summary

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