K-number	K160112
Device name	Besmed PEEP Valve
Applicant	Besmed Health Business Corp
Product code	BYE
Device class	Class II
Decision date	Apr 29, 2016
Decision	Substantially Equivalent
Regulation	868.5965

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Source

View the full FDA submission: accessdata.fda.gov

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Besmed PEEP Valve

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