K-number	K050225
Device name	HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
Applicant	Cambridge Heart, Inc.
Product code	DQK
Device class	Class II
Decision date	Apr 7, 2005
Decision	Substantially Equivalent
Regulation	870.1425

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View the full FDA submission: accessdata.fda.gov

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HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

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