Name: Predicase
Price: 199 USD

K-number	K111191
Device name	AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
Applicant	Wet Nose Technologies, LLC
Product code	CBP
Device class	Class II
Decision date	Jul 28, 2011
Decision	Substantially Equivalent
Regulation	868.5870

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Source

View the full FDA submission: accessdata.fda.gov

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AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

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