K-number	K160636
Device name	iPEP System and vPEP
Applicant	D R Burton Healthcare, LLC
Product code	BWF
Device class	Class II
Decision date	Aug 3, 2016
Decision	Substantially Equivalent
Regulation	868.5690

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Source

View the full FDA submission: accessdata.fda.gov

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iPEP System and vPEP

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