K-number	K230915
Device name	AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
Applicant	Vyaire Medical, Inc.
Product code	CCK
Device class	Class II
Decision date	Nov 12, 2024
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

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AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask