K-number	K150639
Device name	AF541 EE Full Face Mask
Applicant	Respironics, Inc.
Product code	BZD
Device class	Class II
Decision date	Sep 18, 2015
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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AF541 EE Full Face Mask

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