K-number	K160044
Device name	Image1 SPIES System
Applicant	Karl Storz Endoscopy America, Inc.
Product code	FET
Device class	Class II
Decision date	Feb 1, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Image1 SPIES System

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