K-number	K221552
Device name	EFAI ChestSuite XR Pneumothorax Assessment System
Applicant	Ever Fortune.Ai, Co., Ltd.
Product code	QFM
Device class	Class II
Decision date	Nov 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 Pneumothorax Assessment System

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