K-number	K231143
Device name	GI Genius System 100 and GI Genius System 200
Applicant	Cosmo Artificial Intelligence - Ai, Ltd.
Product code	QNP
Device class	Class II
Decision date	May 19, 2023
Decision	Substantially Equivalent
Regulation	876.1520

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Source

View the full FDA submission: accessdata.fda.gov

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GI Genius System 100 and GI Genius System 200

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