K-number	K080116
Device name	TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Applicant	Transonic Systems, Inc.
Product code	DXG
Device class	Class II
Decision date	Sep 8, 2008
Decision	Substantially Equivalent
Regulation	870.1435

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View the full FDA submission: accessdata.fda.gov

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TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

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