K-number	K190683
Device name	External Counterpulsation System
Applicant	Vamed Medical Instrument Co., Ltd.
Product code	DRN
Device class	Class II
Decision date	Sep 10, 2019
Decision	Substantially Equivalent
Regulation	870.5225

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Source

View the full FDA submission: accessdata.fda.gov

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External Counterpulsation System

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