K-number	K132544
Device name	TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
Applicant	Tomtec Imaging Systems GmbH
Product code	LLZ
Device class	Class II
Decision date	Nov 25, 2013
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA

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