K-number	K240291
Device name	EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Applicant	Ever Fortune.Ai, Co., Ltd.
Product code	QAS
Device class	Class II
Decision date	Apr 8, 2024
Decision	Substantially Equivalent
Regulation	892.2080

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View the full FDA submission: accessdata.fda.gov

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EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

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