K-number	K933073
Device name	HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
Applicant	Heartware Intl. Corp.
Product code	IZI
Device class	Class II
Decision date	Oct 7, 1993
Decision	Substantially Equivalent
Regulation	892.1600

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View the full FDA submission: accessdata.fda.gov

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HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE

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