K-number	K161791
Device name	Aer-O-Scope Colonoscope System
Applicant	Gi View , Ltd.
Product code	FDF
Device class	Class II
Decision date	Aug 11, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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Aer-O-Scope Colonoscope System

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