K-number	K151683
Device name	SleepWeaver Advance Pediatric Nasal CPAP Mask
Applicant	Circadiance, LLC
Product code	BZD
Device class	Class II
Decision date	Apr 5, 2016
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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SleepWeaver Advance Pediatric Nasal CPAP Mask

Everything you need for a 510(k) submission. Nothing you don't.