K-number	K162433
Device name	GCE Zen-O Portable Oxygen Concentrator
Applicant	Oxus, Inc.
Product code	CAW
Device class	Class II
Decision date	May 24, 2017
Decision	Substantially Equivalent
Regulation	868.5440

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Source

View the full FDA submission: accessdata.fda.gov

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GCE Zen-O Portable Oxygen Concentrator

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