K-number	K131901
Device name	IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
Applicant	3B Medical, Inc.
Product code	BZD
Device class	Class II
Decision date	Dec 23, 2013
Decision	Substantially Equivalent
Regulation	868.5905

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IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

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