K-number	DEN210006
Device name	Hemolung Respiratory Assist System
Applicant	Alung Technologies, Inc.
Product code	QOH
Device class	Class II
Decision date	Nov 13, 2021
Decision	Not Substantially Equivalent
Regulation	870.4150

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View the full FDA submission: accessdata.fda.gov

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Hemolung Respiratory Assist System

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