K-number	K053084
Device name	SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
Applicant	Kontron Medical Systems Sas
Product code	IYN
Device class	Class II
Decision date	Nov 16, 2005
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

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