K-number	K173483
Device name	Pure Flow External Counter-Pulsation Device
Applicant	Xtreem Pulse, LLC
Product code	DRN
Device class	Class II
Decision date	May 30, 2018
Decision	Substantially Equivalent
Regulation	870.5225

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View the full FDA submission: accessdata.fda.gov

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Pure Flow External Counter-Pulsation Device

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