K-number	K222076
Device name	EFAI ChestSuite XR Pleural Effusion Assessment System
Applicant	Ever Fortune.Ai, Co., Ltd.
Product code	QFM
Device class	Class II
Decision date	Sep 8, 2022
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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EFAI ChestSuite XR Pleural Effusion Assessment System

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