K-number	K223874
Device name	BAROguard
Applicant	Paragonix Technologies
Product code	KDN
Device class	Class II
Decision date	Aug 15, 2023
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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BAROguard

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