K-number	K010261
Device name	CARDIOMEDICS ECP SYSTEM
Applicant	Cardiomedics, Inc.
Product code	DRN
Device class	Class II
Decision date	Feb 28, 2001
Decision	Substantially Equivalent
Regulation	870.5225

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View the full FDA submission: accessdata.fda.gov

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CARDIOMEDICS ECP SYSTEM

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